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“This application under Article 102 of the Constitution has been filed by Human Rights and Peace
for Bangladesh (HRPB) by way of a Public Interest Litigation (PIL) showing concern at the activities of
various authorities in relation to Drug Administration.
Mr. Manzill Murshid, learned advocate has
brought to our notice a report in the Samakal, a national newspaper published on 24.10.2010, which has made reference to the Drug Administration having forgotten
about death of 76 children who died after taking paracetamol syrup in the year 1991. The learned advocate points out that due to the negligence, inaction
and action taken with ulterior motive in order to frustrate
the prosecution of the persons involved in producing and supplying the paracetamol syrup, taking of which led to
the death 76 children in 1991. He points out that the newspaper article clearly shows that the officers concerned, who were at the time employed in the Drug Administration, have made differing statements in
relation to the case which has had the result of minimizing the possibility of any conviction in the case.
The learned advocate has also pointed out another newspaper article appearing in the Daily Inqilub on 24.08.2010, which relates to production and sale of substandard medicines and the inaction of the Drug Administration in monitoring the production and sale of medicines throughout the country. He has also referred to other incidents of maladministration in the provision of medicare to the citizens of this Country.
In view of the above submissions, we are inclined to issue a Rule.
The office is directed to register this application under Article 102 of the Constitution.
Let a Rule Nisi be issued calling upon the respondents to show cause as to why inaction of the respondents to take necessary steps to stop adulteration of drug or medical preparation, which is dangerous to the health of the citizens should not be declared illegal and without lawful authority and why a direction should not be given upon the respondents to take effective measures under section 25(C)of the Special Powers Act, 1974 in case of offence of adulteration of drug or medical preparation, and/or such other or further order or orders passed as to this Court may seem fit and proper.
The Rule is made returnable within 4(four) weeks
from date.
We are concerned that 76 children died in the year 1991 from taking paracetamol syrup and contradictory statements have been made by officials in connection with the prosecution of the case, and in the past 19 years the case has not been concluded for various reasons. We are not aware of the reasons for the delay in concluding the trial.
Hence, pending hearing of the Rule, we are inclined to issue the following directions.
The respondent Nos. 1, 4, 6 and 7 are hereby directed to file affidavit in compliance within 6(six) weeks from date.
Let the matter appear in the list on 13.12.2010 for further orders.
Let the notice be served upon the respondents by FAX as well as by registered post at the cost of the office.”
…l¦aÅf§ZÑ ¢hd¡u Aœ ®j¡LŸj¡l pLm B−cn ¢e−jÀ A¢hLm Ae¤¢mMe
q−m¡x
25.01.2011
Mr. Manzill Murshid, Advocate
-----For the Petitioner
Mr. Md. Motaher Hossain, D.A.G
----- For the Respondents On the prayer of the learned Deputy Attorney
General, this matter is adjourned till 27.01.2011.
B.O (Md. Imman Ali And
Sheikh Hassan Arif, J, J)
27.01.2011
Mr. M. A. Muntakim, Learned Advocate has filed a vokalatnama in court on behalf of the respondent No. 6 which is kept with the record.
B.O (Md. Imman Ali And
Sheikh Hassan Arif, J, J)
Present:
Mr. Justice Md. Imman Ali
And
Mr. Justice Sheikh Hassan Arif
27.01.2011
Mr. Manzill Murshid, Advocate
----- For the Petitioner. Mr. Md. Motaher Hossain, Deputy Attorney General with Mr. Samarendar Nath Biswas, Assistant Attorney General & Mr. Md. Jahangir Alam, Assistant Attorney General
----- For the respondents No. 1 & 2 Mr. Sheikh Awsafur Rahman, Advocate
----- For the respondents No. 5 & 7 Mr. Abdullah Al Bakee, Advocate
----- For the respondents No. 6 The respondents No. 6 and 7 have filed an affidavit
in compliance, which is kept with the record. They have indicated that since they do not have the necessary equipment for the purpose of testing, they could not comply with the directions of this Court.
The respondents No. 1 and 2 have filed an affidavit in compliance, which is dept with the record. The learned Deputy Attorney General has taken us through the affidavit giving details of what steps have been taken since the order of this Court dated 03.11.2010 in respect of formation of Committee, which is empowered to issue guidelines, and samples have been taken for testing quality. So far as the testing is concerned, respondents 1 and 2 have annexed as annexure- VI series reports of 173 samples of drugs taken from various locations. It transpires that the reports are dated from 17.01.2011 to 26.01.2011. It is to be noted that pursuant to the direction of this Court the tests were ordered in a meeting dated 09.01.2011, which was circulated on 25.01.2011. How tests could have been done on 17.01.2011 remains to be seen.
Be that as it may, from the report it is apparent that nine of the samples of medicine tested by the Drug Testing Laboratory are shown to be sub-standard. We note that these items include 1. Capsule- Tetracycline, North-Bengal Pharma Ltd. 2. Capsule-Indo-tetra. M/S Indo-Bangla Pharma Ltd., 3. Capsule-Dyclofenac- (Illegible) Enova Pharma Ltd, 4. Capsulre-N-D North- Bengal Pharma Ltd., 5. (Illegible) Tempil Alco Pharma Ltd., 6. (Illegible) Sepox, Alco Pharma Ltd., 7. Two (Illegible) of Capsule- BT Mox-500, (Illegible) Pharma Ltd., 8. Capsule- B (Illegible) Bengal Techno Pharma Ltd.
These items are all very common medicinal items prescribed everyday. We are not aware as to what action the concerned companies might have already taken in respect of the medicines (Illegible) have been found to the sub-standard. However, we are of the view that once identified as sub-standard they must immediately be taken off the shelf and must not be prescribed to any patient since they could endanger lives of patients.
We, therefore, direct the respondents No. 1 and 2 to take immediate steps of withdraw these items from the market. In this regard they may seek help from the law enforcing agencies including the police and Rapid Action Battalion (RAB). Respondent No. 3. Inspector General of Police (IGP) and respondent No. 4, Director General (DG) of RAB are hereby directed to provide all assistance to respondents No. 1 and 2 in order ensure that the sale of such drugs is (Illegible) and that all the drugs mentioned (Illegible) are immediately removed from all the (Illegible) and shops.
Respondent No. 1 and 2 are further (Illegible) to take immediate steps to prevent (Illegible) production and supply of the drugs mentioned above by the named drug manufacturing companies and to file compliance with regard to clearing the drug from all stores within Dhaka City within two weeks, and from all other stores elsewhere in the country within four weeks from date. The companies concerned may be permitted to manufacture/produce the drugs mentioned only after satisfying the required standard in accordance with law.
Let the matter appear in the list on 28.02.2011 for further orders.
Let the order be communicated by FAX as well as in the usual course immediately.
Sd/- Illegible
Sd/- Illegible
Present:
Mr. Justice Md. Imman Ali
And
Mr. Justice Sheikh Hassan Arif
17.02.2011
Mr. Shamsuddin Babul, Advocate
----- For the applicant. This is an application for addition of party as
respondent No. 9.
The learned advocate for the applicant submits that although the applicant was not a party to the writ petition, his products have been sized and manufacture has been stopped due to a report by the Drug Testing Laboratory, which was done consequent upon an order of this Court dated 27.01.2011. He submits that the applicant is, therefore, a necessary party for proper disposal of the Rue.
No one (Illegible) to oppose the application.
We find substance in the submissions of the learned Advocate, and for the reasons stated in the application for addition of party, the same is allowed.
Let the applicant be added as (Illegible) defendant No. 9.
(Illegible) office is directed to note (Illegible).
Sd/- Illegible Sd/- Illegible
20.03.2011
Present:
Mr. Justice Md. Ashfaqul Islam
And
Mr. Justice S. M. Emdadul Hoque
Mr. Manzil Murshid, Advocate
----- For petitioner. Mr. M. A. Muntakim, Advocate
----- Respondent No. 6 Let the application be kept with the record.
Let this matter be fixed for hearing on 24.04.2011 at the top subject to part heard.
Sd/- Illegible
Sd/- Illegible
24.04.2011
Present:
Mr. Justice Md. Ashfaqul Islam
And
Mr. Justice M. Moazzam Hussain
Mr. Manzil Murshid, Advocate
----- For the petitioner. Let this matter go out of list as this court has no
jurisdiction to hear the matter.
Sd/- Illegible
Sd/- Illegible
13.02.2017
Mr. Manzil Murshid, Advocate
----- For the petitioner. Let this matter be fixed for hearing tomorrow.
Sd/- Illegible
Sd/- Illegible
Present:
Mr. Justice Syed Muhammad Dastagir Husain
And
Mr. Justice Md. Ataur Rahman Khan
16.03.2017
Mr. Manzil Murshid, Advocate
----- For the petitioner. This is an application seeking for a direction upon
the respondent 1-2 to remove Md. Altaf Hossain, Deputy Director and Md. Shafiqul Islam, Assistant Director serving at present at Drug Administration from their post.
Heard the learned Advocate and perused the application.
Considering the facts and circumstance, the Respondent Nos. 1 and 2 is now directed to explain what action they have taken in view of the judgment and order passed in Drug Case No. 3 of 2009 and why they should not be removed from their respective services and to file report what step they have taken as per the order within 2 (two) weeks from the date of receipt of this Order.
The Notice is to be served upon the Respondents by special messenger at the Cost of the office.
Let it appears in the list on 06.04.2017 for further
order.
Sd/- Illegible Sd/- Illegible
Present:
Mr. Justice Syed Muhammad Dastagir Husain
And
Mr. Justice Md. Ataur Rahman Khan
06.04.2017
Mr. Manzil Murshid, Advocate
----- For the petitioner.
Mr. Amit Talukder, D. A. G.
----- For the Respondent. Affidavit in compliance is filed in court today wherein it appears that the committee has been formed consisting of 5 members on 04.04.2017 but no date has been fixed for submission of report, as such the Respondent No. 1 is directed to fix a date to submit the report by the committee as constituted.
Let it appear in the list on 08.05.2017 for further
order.
Application for addition of party is kept with the record.
Sd/- Illegible Sd/- Illegible
08.05.2017
No one appears
----- For the petitioner.
Mr. Md. Jahangir Alam, A. A. G.
----- For the Respondents. As per order dated 06.04.2017 the committee was directed to submit report on the date fixed but as it appears no date has been fixed rather the member secretary of the inquiry committee has submitted that to
submit report it requires 16 weeks. In this connection the member secretary is directed to submit his report within 10 weeks from to-day i.e. within 18 July, 2017.
Let it appear in the list on 23.07.2017 for further order.
Sd/- Illegible Sd/- Illegible
Present:
Mr. Justice Syed Muhammad Dastagir Husain
And
Mr. Justice Md. Ataur Rahman Khan
03.08.2017
Mr. Manzil Murshid, Advocate
----- For the petitioner. Mr. Amit Talukder, D. A. G. with
Mr. Md. Jahangir Alam, A. A. G
----- For the Respondents. This is an application for not to accept the recommendation No. 1 of the Inquiry Committee report dated 11.07.2017.
Mr. Manzil Murshid, the learned Advocate appearing on behalf of the petitioner submits that the instant Writ Petition was filed for the purpose of public interest litigation under Article 102 of the Constitution of the Peoples Republic of Bangladesh challenging the inaction to take necessary steps to stop adulteration of drug or Medical preparation. He further submits that a Rule was issued upon the respondents and also an ad- interim order to form a high power committee to formulate monitoring guideline to stop adulteration of drug and medical preparations. He further submits that the Rule was issued arising out of a report about production and sale of adulterate medicine causing health risk to the citizen, 76 children were died due to
taking adulterated paracitamal syrup. Subsequently a case was started being Drug Case No. 03 of 2009 about the matter and as per direction, the Drug authority form a committee and submitted a compliance report and trial was concluded and Judgment was passed on 28.11.2016, wherein all the acused persons were acquitted with findings that both the accused persons, Superintendent, department of Medicine namely, Md. Shafiqul Islam and Md. Altaf Hossain are found to the extreme negligent incompetent and inefficient of their responsibilities. Both of them are serving under the Drug Administration authority, no departmental proceedings as yet been started against them, not they were removed from their post, not have taken any action/steps against those persons who are responsible for the death of such children. Under such circumstances, the instant application for not to accept the recommendation No. 1 and as to why the respondent Nos. 1 and 2 have not removed namely Superintendent, department of Medicine, namely, Md. Shafiqul Islam and Md. Altaf Hossainw who are serving under the Drug Administration authority.
Heard the learned Advocate for the petitioner, perused the application. It appears that there was a serious allegation that 76 children died due to taking adulterated Paracitamal syrup. There was a report by the Inquiry Committee submitted to the respondent Nos. 1 and 2 who have the responsibility to look into the matter and to take initiative of such adulteration. Despite of the report against Superintendent, Department of Medicine, Md. Shafiqul Islam and Md. Altaf Hossain are still serving under the Drug Administration authority though they were absolutely liable for such occurrence but the respondents did not take any steps against those persons.
Considering all these facts circumstances, the respondent Nos. 1 and 2 are directed to send a report within 3 (three) days from the date of receipt of this order, what actions have they taken against the persons
as named above.
Let it appear in the list on 13.08.2017.
Communicate the order at the cost of office.
Sd/- Illegible
Sd/- Illegible
13.08.2017
j¡ee£u ®L¡−VÑl 03.08.2017 Cw a¡¢l−Ml B−cn ®j¡a¡−hL 1 J 2 ew ¢hh¡c£ hl¡hl kb¡l£¢a S¡l£ q−u−Rz S¡l£l fТa−hce fÐn¡p¢eL e¢b−a e¢bi¥š² Ll¡ q−m¡z
ü¡/- AØfø
13.08.2017
Mr. Manzil Murshid, Advocate
----- For the petitioner.
Mr. Amit Talukder, D. A. G.
----- For the Respondents. The learned Deputy Attorney General appearing
on behalf of the Respondents submits that he will file affidavit in compliance as such requires time.
In view of submission made by the learned Deputy Attorney General, let it appear in the list on 16.08.2017 for further order.
Sd/- Illegible
Sd/- Illegible
21.08.2017
Mr. Manzil Murshid, Advocate
----- For the petitioner. Mr. Amit Talukder, D. A. G.
----- For the Respondents.
To-day the affidavit in compliance has been filed
by the learned Deputy Attorney General and it appears
that the respondent No. 1 the Secretary of Ministry of
Health, Bangladesh Secretariat has informed that Mr.
Md. Altaf Hosain and Mr. Md. Shafiqul Islam have been
warned by two memos dated 17.08.2017 and those have
been annexed as Annexure- 27, 28 & 29.
On this context the learned Advocate for the petitioner has submitted that the Secretary himself could
not understand what was the spirit of the Order. The
Order itself shows that 76 Children died due to taking adulterated Paracitamal syrup. There was a report by the
Inquiry Committee and the respondent Nos. 1 and 2 have
the responsibility to look into the matter and to take initiative of such adulteration and despite of such order
the Secretary of Health did not any take any responsibility nor any initiative against the two officers
Mr. Md. Altaf Hosain and Mr. Md. Shafiqul Islam. If Secretary himself could not understand the spirit of the
Order then he has to explain his position in this regard
by appearing before this Court and as such we direct the Respondent No. 1 Mr. Md. Shirajul Hoque Khan, the Secretary Ministry of Health and Family welfare, Bangladesh Secretariat. P. S. Shahagh, Dhaka to appear
in person to explain his position at 10.30 am positively
on 23rd August, 2016.
Office is directed to communicate the order immediately at the cost of the Office.
Sd/- Illegible
Sd/- Illegible
23.08.2017
j¡ee£u ®L¡−VÑl 21.08.2017 Cw a¡¢l−Ml B−cn 1ew ¢hh¡c£ hl¡hl kb¡l£¢a S¡l£ q−u−Rz S¡l£l fТa−hce fÐn¡p¢eL e¢b−a e¢bi¥š²
Ll¡ q−m¡z
ü¡/- AØfø
Present:
Mr. Justice Syed Muhammad Dastagir Husain
And
Mr. Justice Md. Ataur Rahman Khan
23.08.2017
Mr. Manzil Murshid, Advocate
----- For the petitioner. Mr. Qumrul Hoque Siddiqui, Advocate
----- For the Respondent No.1.
Mr. Amit Talukder, D. A. G with
Mr. Md. Jahangir Alam, A. A. G, and
Mr. Shafiqul Islam Siddique, A. A. G
----- For the Respondents. The Respondent No. 1 has personally appeared in
court to-day.
The Supplementary affidavit in compliance on behalf of the respondent No. 1 is not at all accepted as that has been sworned by an authorized person.
Thus the supplementary affidavit in compliance is rejected.
However, on the prayer of the learned advocate appearing on behalf of the Respondent No. 1 this matter is adjourned till tomorrow for filing affidavit in compliance in a proper way but the appearance is not dispensed with.
Sd/- Illegible
Sd/- Illegible
Present:
Mr. Justice Syed Muhammad Dastagir Husain
And
Mr. Justice Md. Ataur Rahman Khan
24.08.2017
Mr. Manzil Murshid, Advocate
----- For the petitioner.
Mr. Mahbubey Alam, Attorney General with
Mr. Amit Talukder, D. A. G.
----- For the Respondents. Mr. M. Qumrul Hoque Siddique, Advocate
----- For the Respondent No. 1. To-day the Respondent No. 1 is present and appeared before this court. He has filed further affidavit of compliance and also submits that already they have complied with the order and prayed for unconditional apology.
Under such circumstances, the appearance of the respondent No. 1 is dispensed with.
The affidavit of compliance is accepted and be kept with the record.
Sd/- Illegible
Sd/- Illegible
Present:
Mr. Justice Syed Muhammad Dastagir Husain
And
Mr. Justice Md. Ataur Rahman Khan
17.10.2017
Mr. Manzil Murshid, Advocate
----- For the petitioner. This is an application filed on behalf of the petitioner for staying the order dated 28.09.2017 passed in Administrative Tribunal Case No. 314 of 2017 staying the order of suspension of Assistant Director Md. Shafiqul Islam and further direction upon the respondent No. 2 Md. Mustafizur Rahman to appear in person before this court on 23.10.2017 to explain his conduct.
The learned advocate for the petitioner submits that it is the case of Paracitamal Syrup where 76 child expired due to taking of adulterated paracitamal syrup. The Secretary Ministry of health passed an order of
suspension against Md. Shafiqul Islam, Assistant
Director and the matter is pending before this court. Md.
Shafiqul Islam, Assistant Director filed an Administrative
Tribunal Suit No. 2014 of 2017 challenging the suspension order dated 23.08.2017 and obtained an
order of stay and the Respondent No. 2 Md. Mustafizur Rahman, Director General, Drug Administration allowed
him to work knowing full well that a suspension order is
there and a proceeding is pending before this court a violation of order of this court.
Under such circumstances the order dated 28.09.2017 passed by Administrative Tribunal No. 1,
Dhaka being Case No. 314 of 2017 is stayed for a period
of 3 (three) months. The Respondent No. 2 Md. Mustafizur Rahman. Director General, Drug Administration is to explain his conduct as to why
knowing full well about the proceeding pending before
this court, he has permitted Md. Shafiqul Islam to work
as it appears from the order sheet-dated 04.10.2017
though the order of suspension has not been re-called.
He had to explain to the satisfaction before this court
within 7 days from the date of receipt of this order.
Let it appear in the list on 29.10.2017 for further
order.
Sd/- Illegible
Sd/- Illegible
29.10.2017
j¡ee£u ®L¡−VÑl 17.10.2017 Cw a¡¢l−Ml B−cn 2ew ¢hh¡c£ hl¡hl kb¡l£¢a S¡l£ q−u−Rz S¡l£l fТa−hce fÐn¡p¢eL e¢b−a l¡M¡ q−m¡z
ü¡/- AØfø
29.10.2017
Mr. Shah Munjurul Hoque, for
Mr. Abdul Matin Khasru, Advocate
----- For the Respondent No. 2. On the prayer of the learned Advocate for the Respondent No. 2 this matter is adjourned for 1 (one) week.
B. O. (Syed Md. Dastagir Husain And
Md. Ataur Rahman Khan, J. J)
Present:
Mr. Justice Syed Muhammad Dastagir Husain
And
Mr. Justice Md. Ataur Rahman Khan
06.11.2017
Mr. Manzil Murshid, Advocate
----- For the petitioner. Mr. Abdul Matin Khasru, Senior Advocate with
Mr. Palash Chandra Roy, Advocate
----- For the Respondent No. 2. Mr. Amit Talukder, D. A. G.
----- For the respondents.
In pursuance of court’s order dated 17.10.2017, Md. Mustafizur Rahman, Director-General, Drug Administration, Motijheel Commercial Area, Dhaka as respondent No. 2 has filed an explanation through his engaged lawyer and begs Unconditional apology by annexing Annexure- X-4, wherein he stated that the delinquent personal is under suspension.
Considering the above facts and circumstances, affidavit sworn by Director-General, Drug Administration as respondent No. 2 Md. Mustafizur Rahman is hereby accepted.
Sd/- Illegible
Sd/- Illegible
Present:
Mr. Justice Syed Muhammad Dastagir Husain
And
Mr. Justice Md. Ataur Rahman Khan 16.11.2017
Mr. Manzil Murshid, Advocate
----- For the petitioner. Mr. Md. Zakir Hossain Masud, Advocate
----- For the applicants.
Mr. Md. Ariful Islam with
Mr. Mohammad Mijanur Rahman, Advocate
----- For the applicant-added respondent No. 10. Mr. Amit Talukder, D. A. G.
----- For the Respondents.
Mr. Md. Zakir Hossain Masud, the learned Advocate for the applicant of addition of party on behalf of (1) Md. Altaf Hossain, Deputy Director and (2) Md. Shafiqul Islam, Assistant Director, Directorate General of Drug Administration, Medicine Bhaban, Mohakhali, Dhaka submits that he has instructions not to press the application for addition of party, hence it is rejected as being not pressed.
Another application for addition of party as respondent No. 10 is filed by Mr. Md. Ariful Islam.
Mr. Md. Ariful Islam, the learned Advocate for the applicant submits that the applicant was not made a party in the instant writ petition and the applicant has got interest, as such, he is required to be added as a party as respondent No. 10 in the Writ Petition.
The learned Advocate for the Petitioner did not oppose the application for addition of party.
Heard the learned Advocates and perused the application.
Considering the facts and circumstances, since the applicant has got interest in the subject matter of this case, let the applicant be added as party.
Let the applicant Md. Shafiqul Islam, Assistant Director, Directorate of Drug Administration, Mohakhali, Dhaka be added as respondent No. 10 in the instant Writ Petition.
The office is directed to note accordingly.
Sd/- Illegible
Sd/- Illegible 06.12.2017
Mr. Mohammad Mijanur Rahman, Adv.
----- Respondent No. 10. The application for vacating the order of stay is
kept with the record.
B. O. (Syed Md. Dastagir Husain And
Md. Ataur Rahman Khan, J. J)
01.02.2018
Present:
Mr. Justice Syed Muhammad Dastagir Husain
And
Mr. Justice Md. Ataur Rahman Khan
Mr. Manzil Murshid, Advocate
----- For the petitioner.
Let the order of stay granted earlier by this court in administrative tribunal No. 1 Dhaka being Case No. 314/2017 be extended for a further period 6 (six) months from date of expiry.
Sd/- Illegible
Sd/- Illegible
23.07.2018
Present:
Mr. Justice Syed Muhammad Dastagir Husain
And
Mr. Justice Md. Iqbal Kabir
Mr. Manzil Murshid, Advocate
----- For the petitioner.
Let the order of stay granted earlier by this Court in case No. 314 /2017 of Administrative Tribunal No. 1, Dhaka be extended for a further period of 1 (one) year from date.
Sd/- Illegible
Sd/- Illegible 07.10.2018
Mr. Mohammad Mijanur Rahman, Adv
----- For the Respondent No. 10. Let this matter be fixed for hearing.
Sd/- Illegible
Sd/- Illegible 14.10.2018
Mr. Habibul Islam Bhuiyan with
Mr. Mohammad Mijanur Rahman, Adv
----- For the Respondent No. 10.
Heard in part.
B. O. (Syed Md. Dastagir Husain And
Md. Ataur Rahman Khan, J. J)
23.10.2018
On the prayer of the learned Advocate on behalf of the petitioner this matter is adjourned till 31.10.2018.
B. O. (Naima Haider
And
Khizir Ahmed Chowdhury, J. J)
01.11.2018
On the prayer of the learned Advocate on behalf of respondent, this matter is adjourned till 04.11.2018 as a last change.
B. O. (Naima Haider
And
Khizir Ahmed Chowdhury, J. J)
04.11.2018
Mr. Manzil Murshid with
Mr. Asaduzzaman Siddiqur, Advocate
----- For the petitioner. Mr. Mohammad Mijanur Rahman, Advocate
----- For the Respondent No. 10. Heard-in-part.
B. O. (Naima Haider
And
Khizir Ahmed Chowdhury, J. J)
11.11.2018
Mr. Manzil Murshid with
Mr. Asaduzzaman Siddiqur, Advocate
----- For the petitioner. Mr. Md. Habibul Islam Bhuiyan with
Mr. Mohammad Mijanur Rahman, Advocate
----- For the Respondent No. 10. For the respondent No. 10 let this matter be not
treated as in Heard-in-part.
Sd/- Illegible
Sd/- Illegible
Present:
Mr. Justice F. R. M. Nazmul Ahasan
And
Mr. Justice K. M. Kamrul Kader
07.02.2019
Mr. Mohammad Saifuddin Khokon, Advocate
----- For the applicant-petitioner.
This is an application for addition of party.
The application is not opposed.
Heard the learned Advocate and perused the application. For the reasons stated therein, we are inclined to allow the application. Accordingly, the application is allowed.
Let the applicant be added as Respondent No. 11.
Office is directed to do the needful in accordance with law.
Sd/- Illegible
Sd/- Illegible
30.04.2019
Mr. Mohammad Saifuddin Khokon the learned Advocate by power filed on behalf of the respondent No. 10 be kept record.
B. O. (F. R. M. Nazmul Ahsan And
K. M. Kamrul Kader, J. J)
30.04.2019
Mr. Manzil Murshid, Advocate
----- For the petitioner. Mr. Robiul Alam with
Mr. Mohammad Saifuddin Khokon, Advocate
----- For the Respondent No. 11. Let this matter go out of list for the time being.
Sd/- Illegible
Sd/- Illegible
Present:
Mr. Justice Moyeenul Islam Chowdhury
And
Mr. Justice Md. Ashraful Kamal
14.05.2019
Mr. Manzill Murshid, Advocate
----- For the petitioner-applicant.
On second thoughts, Mr. Manzill Murshid, learned Advocate appearing on behalf of the applicant, submits that he will not press the application dated 05.05.2019 for direction. Accordingly, the application is rejected as being not pressed.
Sd/- Illegible
Sd/- Illegible
14.07.2019
Mr. Manzill Murshid, Advocate
----- For the petitioner.
Let this matter be fixed for hearing on 28.07.2019.
Sd/- Illegible
Sd/- Illegible 18.07.2019
Mr. Manzill Murshid, Advocate
----- For the petitioners. Mr. Md. Robiul Alam (Budu), Advocate
----- For the respondent Nos. 10-11.
This is an application for issuance of a Supplementary Rule.
Having place the application, Mr. Manzill Murshid, learned Advocate for the petitioners submits that the petitioner filed the instant Writ Petition challenging the inaction of the respondents in taking necessary steps to stop adulteration of drug or medical preparation following the death of 76 children due to consumption of adulterated paracetamol syrup and other medicine of the same chemical composition, which gave rise to a criminal case, namely, Drug Case No. 03 of 2009 under section 16(a), (c) and section 17 of the Drug Control Ordinance, 1982 disposed of with the finding that the charges against the accused persons could not be proved due to the gross negligence, inefficiency and incompetence of respondent Nos. 10 and 11 and the copy of the said judgment was sent to the Secretary, Ministry of Health and Family Wealfare for information and taking necessary action, but upon drawing proceeding against them, the proceeding was disposed of with a minor penalty and subsequently, by the orders dated 31.03.2019 both of them have been reinstated in their service upon withdrawing the suspension order and they have been posted to their earlier posts and as such, in such facts and circumstances, the petitioner has filed the application for issuance of a Supplementary Rule as has been prayed for.
Mr. Md. Robiul Alam (Budu), learned Advocate for the respondent Nos. 10 and 11 submits that since a Criminal Appeal is pending against the judgment and order of acquittal passed in the said Drug Case No. 03 of 2009, the respondents should not be prejudiced in their service before disposal of the said Criminal Appeal inasmuch as the original Rule is pending before this Court for hearing and as such, the application may be disposed of along with the Rule.
We have perused the application along with the records of the Writ Petition as well as the judgment and order passed in Drug Case No. 03 of 2009 and heard the learned Advocates from both the sides.
In the facts and circumstances, we find substance in the submission of the learned Advocate for the petitioner, while we also find substance in the submission of the learned Advocate for the respondent Nos. 10 and 11 as to that pending disposal of the Criminal Appeal, they should not be prejudiced in their service. Accordingly, we are inclined to issue a Supplementary Rule.
Let a Supplementary Rule Nisi be issued calling upon the respondents to show cause as to why the office order dated 31.03.2019 bearing Memo No. 45.150.027.01.00.070.2018-245 (Annexure- D) and the office order dated 31.03.2019 bearing Memo No. 45.150.027.01.00.070.2018-246 (Annexure- D-1) issued by the respondent No. 1 should not be declared to have been passed without lawful authority and are of no legal effect and/or why such other or further order of orders as to this Court may seem fit and proper, shall not be passed.
Since it appears from the judgment and order passed in the said Drug Case No. 03 of 2009 that not only due to the gross negligence, inefficiency and incompetence of the respondent Nos. 10 and 11 the allegations were not proved, but both of them were Superintendent of Drugs at the time of the saddening death of 76 children, it is not prime facie safe to keep them in any charge of the Drug Administration till disposal of the Rule.
Accordingly, pending hearing of the Rule, the respondent Nos. 10 and 11 are hereby restrained from performing any function in connection with the affairs of the Drug Administration.
However, the respondent Nos. 1 and 2 may provide their service otherwise.
The Rule is made returnable within 2 (two) weeks from date.
Since the respondents have already made their appearance, there is no necessity for serving the Rule on them.
Sd/- Illegible
Sd/- Illegible
Bf£m ¢hi ¡−Nl ¢hNa Cw−lS£ 13.10.2019 Hhw 09.12.2019 a¡¢l−Ml B−cnàu ¢e−jÀ A¢hLm Ae¤¢mMe q−m¡x
IN THE SUPREME COURT OF BANGLADESH APPELLATE DIVISION
Present:
Mr. Justice Syed Mahmud Hossain, Chief Justice
Mr. Justice Hasan Foez Siddique
Ms. Justice Zinat Ara
Mr. Justice Md. Nuruzzaman
CIVIL MISCELLANEOUS PETITION NO. 640 OF 2019 (From the order dated 18.07.2019 passed by the High Court Division in Writ Petition No. 9105 of 2010).
Md. Shafiqul Islam and another.
----- Petitioners.
-Versus-
Human Rights and Peace for Bangladesh (HRPB), represented by it’s President, Advocate Manzill Murshid and others.
----- Respondents.
For the Petitioners : Mr. Satya Ronjon Mondall,
Advocate-on-Record.
For Respondent No. 1 : Mr. Monzill Murshed,
Advocate instructed by Mr. Md. Nurul Islam Chowdhury, Advocate-on- Record.
Respondent Nos. 2-11 : Not represented.
Date of hearing : The 13th October 2019.
O R D E R
This is an application for vacating of the order of stay dated 23.07.2019 passed by the learned Judge-in- Chamber in Civil Miscellaneous Petition No. 640 of 2019.
Heard the learned counsel appearing for the applicant/respondent No. 1 and perused the application. Considering all aspects of the matter, we are inclined to vacate the order of stay passed by the learned Judge-in- Chamber. The order of stay dated 23.07.2019 passed by the learned Judge-in-Chamber is vacated.
Accordingly, the application is allowed.
Sd/- S. M. Hossain, C.J
Sd/- Hasan Foez Siddique, J Sd/- Zinat Ara, J
Sd/- Md. Nuruzzaman, J
IN THE SUPREME COURT OF BANGLADESH APPELLATE DIVISION
Present:
Mr. Justice Syed Mahmud Hossain, Chief Justice Mr. Justice Hasan Foez Siddique
Mr. Justice Md. Nuruzzaman
CIVIL PETITION FOR LEAVE TO APPEAL NO. 3118 OF 2019
(From the order dated 18.07.2019 passed by the High Court Division in Writ Petition No. 9105 of 2010).
Md. Shafiqul Islam and another.
----- Petitioners.
-Versus-
Human Rights and Peace for Bangladesh (HRPB), represented by it’s President, Advocate Manzill Murshid and others.
----- Respondents.
For the Petitioners : Mr. A. M. Aminuddin, Senior
Advocate instructed by Mr. Syed Mahbubar Rahman, Advocate-on-Record.
For Respondent No. 2 : Mr. Ruhul Quddus, Advocate
instructed by Mr. Md. Nurul Islam Chowdhury, Advocate- on-Record.
Respondent No. 1 & 3- : Not represented.
11
Date of hearing : The 09th December, 2019.
O R D E R
This petition for leave to appeal is directed against an interim order dated 18.07.2019 of the High Court Division in Writ Petition No. 9105 of 2010.
We have heard the learned counsel of both the parties and perused the impugned order of the High Court Division and the other materials on record. Upon hearing the parties, we are of the view that the ends of justice would be best served, if the Rule itself is disposed of on merit by the High Court Division.
Let the Rule be heard and disposed of by the Division Bench of the High Court Division presided over by Md. Ashraful Kamal, J., Expeditiously.
However, the operation of the order dated 18.07.2019 passed by the High Court Division in Writ Petition No. 9105 of 2010 so far it relates to restraining the respondent Nos. 10 and 11 from performing any function in connection with the affairs of the Drug Administration be stayed till disposal of the Rule.
The leave petition is disposed of with the above observations and directions.
Sd/- S. M. Hossain, C.J
Sd/- Hasan Foez Siddique, J
Sd/- Md. Nuruzzaman, J 06.01.2020
Mr. Manzill Murshid, Advocate
----- For the petitioner.
Let this matter be fixed for hearing on 20.01.2020.
Sd/- Illegible
Sd/- Illegible 29.01.2020
Mr. Manzill Murshid, Advocate
----- For the petitioner. Heard in part and adjourned to 10.02.2020
B. O. (Md. Ashraful Kama And Razik-Al-Jalil, J. J)
08.11.2020
frN−Zl B−hc−el ®fТr−a AcÉ ®j¡LŸj¡¢V öe¡e£ j¤mah£ Ll¡ qmz flhaÑ£ öe¡e£ 10.01.2021z
ü¡/- AØfø ü¡/- AØfø
27.01.2021
Mr. Manzill Murshid, Advocate
----- For the petitioner. Hearing concluded and judgment on 02.03.2021.
B. O. (Md. Ashraful Kama And Razik-Al-Jalil, J. J)
02.03.2021
Mr. Manzill Murshid, Advocate
----- For the petitioner. Judgment deferred to 07.04.2021.
B. O. (Md. Ashraful Kama And Razik-Al-Jalil, J. J)
21.06.2021
frN−Zl B−hc−el ®fТr−a AcÉ ®j¡LŸj¡¢Vl l¡u 1 pç¡−ql SeÉ j§mah£ Ll¡ q−m¡z
B−cnœ²−j
ü¡/- AØfø ü¡/- AØfø
29.06.2021
Mr. Manzill Murshid, Advocate
----- For the petitioner.
Judgment deferred to 06.07.2021.
B. O. (Md. Ashraful Kama And Razik-Al-Jalil, J. J)
20.01.2022
Mr. Manzill Murshid, Advocate
----- For the petitioner. Mr. Mohammad Saifuddin Khokon, Advocate
-----For the Opposite Party No. 10.
Judgment deferred to 20.02.2022.
B. O. (Md. Ashraful Kama And Razik-Al-Jalil, J. J)
clM¡Ù¹L¡l£ f−r ¢h‘ HÉ¡X−i ¡−LV j e¢Sm ®j ¡l−pc ¢hÙ¹¡¢lai ¡−h
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Kiv nq bvB wKsev AÎ †imcb‡W›UMY fri¥š² wQ‡jb bv| cieZ©x‡Z AÎ
frNZ fri¥š² nb| Zvic‡i MZ 18/07/19 Bs Zvwi‡L nvB‡KvU© wefvM wb¤œwjwLZfv‡e m¤ú~iK l¦m wbwk Rvix K‡ib|
“ This is an application for issuance of a Supplementary Rule.
Having place the application, Mr.
Manzill Murshid, learned Advocate for the petitioners submits that the petitioner filed
the instant Writ Petition challenging the
inaction of the respondents in taking necessary steps to stop adulteration of drug
or medical preparation following the death
of 76 children due to consumption of adulterated paracetamol syrup and other
medicine of the same chemical composition,
which gave rise to a criminal case, namely,
Drug Case No. 03 of 2009 under section
16(a), (c) and section 17 of the Drug
Control Ordinance, 1982 disposed of with
the finding that the charges against the
accused persons could not be proved due to
the gross negligence, inefficiency and incompetence of respondent Nos. 10 and 11
and the copy of the said judgment was sent
to the Secretary, Ministry of Health and
Family Wealfare for information and taking
necessary action, but upon drawing proceeding against them, the proceeding was disposed of with a minor penalty and subsequently, by the orders dated 31.03.2019 both of them have been reinstated in their service upon withdrawing the suspension order and they have been posted to their earlier posts and as such, in such facts and circumstances, the petitioner has filed the application for issuance of a Supplementary Rule as has been prayed for.
Mr. Md. Robiul Alam (Budu), learned Advocate for the respondent Nos. 10 and 11 submits that since a Criminal Appeal is pending against the judgment and order of acquittal passed in the said Drug Case No. 03 of 2009, the respondents should not be prejudiced in their service before disposal of the said Criminal Appeal inasmuch as the original Rule is pending before this Court for hearing and as such, the application may be disposed of along with the Rule.
We have perused the application along with the records of the Writ Petition as well as the judgment and order passed in Drug Case No. 03 of 2009 and heard the learned Advocates from both the sides.
In the facts and circumstances, we find substance in the submission of the learned Advocate for the petitioner, while we also find substance in the submission of the learned Advocate for the respondent Nos. 10 and 11 as to that pending disposal of the Criminal Appeal, they should not be
prejudiced in their service. Accordingly, we
are inclined to issue a Supplementary Rule.
Let a Supplementary Rule Nisi be
issued calling upon the respondents to show
cause as to why the office order dated 31.03.2019 bearing Memo No. 45.150.027.01.00.070.2018-245 (Annexure- D) and the office order dated 31.03.2019 bearing Memo No. 45.150.027.01.00.070.2018-246 (Annexure-
D-1) issued by the respondent No. 1 should
not be declared to have been passed without
lawful authority and are of no legal effect
and/or why such other or further order of
orders as to this Court may seem fit and
proper, shall not be passed.
Since it appears from the judgment
and order passed in the said Drug Case No.
03 of 2009 that not only due to the gross negligence, inefficiency and incompetence of
the respondent Nos. 10 and 11 the allegations were not proved, but both of
them were Superintendent of Drugs at the
time of the saddending death of 76 children,
it is not prime facie safe to keep them in any
charge of the Drug Administration till disposal of the Rule.
Accordingly, pending hearing of the
Rule, the respondent Nos. 10 and 11 are
hereby restrained from performing any
function in connection with the affairs of the
Drug Administration.”
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cieZx© Civil Petition for Leave to Appeal No. 3118 of 2019
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No. 10 and 11)|
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DRUG CONTROL COMMITTEE
Drug Control Committee has been formed as per The Drug (Control) Ordinance, 1982, Section 4(1), And dated
on the 19th October, 2009 The Drug Control Committee amended and revised vide the memo No. Seü¡ÙÛÉ-1/Kod- 4/2008/372, a¡¢lMx 19.10.2009.
The jurisdiction of the 21 member committee are as follows:
as per the Drug (Control) Ordinance 1982, Section 4(2), 5(2), 6(2) and 6(3).
The activities of the Drug Control Committee (DCC) of the last two years.
Decision: The registration of the products containing Tacrolimus, Pimecrolimus & Hydroquinone would be existed.
C. Regarding the approval of different combination of vitamins and minerals: Among the 16 different combinations of vitamins and minerals 3 combination were approved and 13 rejected.
D. Antioxidant preparation (Vitamin A + C + E)- Multiple Vitamin-Mineral Combinations/Individual Minerals/Varieties of combination of hematinics with micronutrients To examine the recommendations made by the committee formed before on the above combinations as expert committee has been formed to submits their reports with opinion to the Technical Sub-Committee of DCC.
E. Product for local manufacture (Human)
* 190 products approved.
* 174 products rejected.
* For 25 products instructed to reply with necessary acceptable references and safety related documents.
* A committee has been formed for three products to evaluate safety, efficacy and usefulness and to submit report with data, elaborate documents to Technical Sub-Committee of DCC.
F. Products for local manufacture (Veterinary)
* 20 products approved.
* 1 product rejected.
G. Products for Importation (Human)
* 55 products approved.
* 37 products rejected.
* For 8 products instructed to reapply with sufficient documents and papers.
* Palce again to TSC-1 product.
H. Products for Importation (Veterinary)
* 73 products approved.
* 24 products rejected.
* To give opinion on one product to place in the next meeting of Technical Sub-Committee.
* To reaply-1 product.
I. Medical Device for Local Manufacture
* 2 products were approved.
J. Surgical equipments for import
* 5 products were approved.
K. Gauze and Bandage
* 6 products approved.
* 5 products rejected.
L. Regarding the Registered Drugs of which the DCC approval references are not available
* Human Drugs: 223
* Veterinary Drugs: 195
* Imported Human Drugs: 34
Decision: Would be considered as approved by DCC.
Decision: Application of such vaccines would be presented in DCC meeting.
Enclosure:
1. The minutes of the 238th DCC Meeting is enclosed.
Sd/- Illegible
Maj Gen Md. Abul Kalam Azad
Director General
Directorate General of Drug Administrating
&
Licencing Authority Drugs Government of the Peoples Republic of Bangladesh
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mß`k: AZ¨vek¨Kxq Jl‡ai mnRjf¨Zv I g~j¨ wbqš¿Y wbwðZ Kiv|
Aó`k : Rjevqy cwieZ©bRwbZ ¯^v¯ ¨’ wech©q I †ivM e¨vwai MwZ cÖK…wZ
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g~j KviY| GQvov G D”Pnv‡ii Ab¨vb¨ cÖavb KviY n‡jv: cv Ö_wgK Ges
gvZ…‡mevi Ach©vßZv, cvwievwiK Ges mvgvwRK Rxe‡b m‡PZbZvi Afve,
kw³kvjx ¯^v¯’¨ e¨e¯’vi Abycw¯’wZ Ges `¶ cÖwk¶YcÖvß avÎxi Ach©vßZv|
wkïg„Z¨yi nvi Kgv‡bvi Rb¨ mKj Kvh©vewji mdj cÖ‡qvM mË ‡¡I gvZ…g„Z¨yi gZ wkïg„Z¨yi nv‡ii cv_©K¨ j¶¨Yxq (kn‡ii e—, w¯ cvnvwo
Ges DcK‚jeZ©x GjvKv, cwi‡ekMZ msKUvcbœ A‡j Zv †ewk)| Gi
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bv| wkï g„Z¨yi cÖavb KviY¸‡jv n‡jv: wbD‡gvwbqv, Wvqwq iv, Acywó,
cvwb‡Z Wz‡e hvIqv, welwµqv Ges AvNvZ; G welq¸‡jv‡Z `„wó †`qv
cÖ‡qvRb| wkïi 6 gvm eqm ch©š— ¯—b¨cvb Ges h_vmg‡q †Zvjv Lvevi
cÖ`v‡bi cÖwZI AwaKZi ¸i“Z¡ cÖ`vb Kiv cÖ‡qvRb|
KwZcq A‡j g¨v‡jwiqvi cÖ‡Kvc Ges eû Jla cÖwZ‡ivax h²v,
†Mv` †ivM, K…wg Ges KvjvR¡i, GBPAvBwf/GBW‡mi ûgwK, b RM‡Yi
my¯^v¯ ¨’ AR©‡bi c‡_ Aš—ivq n‡q `vuwo‡q‡Q| GBPAvBwf/GBW‡mi e¨vcv‡i h_v‡hvM¨ bRi`vwi, D”P SzuwKc~Y© †Rjv¸‡jv‡Z g¨v‡jwiqvi cÖv`yf©ve †iv‡a kw³kvjx gwbUwis e¨e¯ v’ , GKvwaK Jla cÖwZ‡ivax
g¨v‡jwiqv Ges h²vi Rb¨ Kvh©Kix wPwKrmv e¨e¯ v’ Ges KvjvR¡i
cÖwZ‡iva, wPwKrmv Ges †ivM wbY©‡q AMÖMwZ BZ¨vw` DbœZ ¯^v¯’¨‡mevi Awe‡”Q`¨ A½| dvB‡jwiqv Ges gvwU evwnZ K…wg †ivM we— ¯vi cÖwZ‡iv‡a
Av‡iv Kvh©Ki c`‡¶c †bqv cÖ‡qvRb|
MZvbyMwZK AmsµvgK †ivM †hgb- K¨vÝvi, Wvqv‡ewUm, D”P i³Pvc, k¦vmZ‡š¿i †ivM, ü`‡ivM Ges †÷ªvK cÖf…wZi cÖ‡K vcµgvš^‡q
evo‡Q| GQvov MZvbyMwZK bq Ggb †ivM †hgb- gvbwmK ¯^v¯’¨ mgm¨v, moK-‡ij-‡bŠ `yN©Ubv, wewfbœ ai‡Yi ˆ`wnK I gvbwmK Amvg_¨©-mg~n,
cvwb‡Z †Wvev, †cvov, kªeY I `„wókw³ mgm¨v BZ¨vw` eZ©gv‡b eo ai‡bi
P¨v‡jÄ wn‡m‡e MY¨ Kiv n‡”Q| eû msL¨K gvbyl Av‡m©wbK-`~wlZ cvwb
e¨envi Ki‡Q Ges djkª“wZ‡Z Av‡m©wbK msµvš— e¨vwa‡Z Avµvš—
n‡”Q| ˆkke-Kvjxb Dbœqb msµvš— c`‡¶cmg~‡ni g‡a¨ †gavD bœq‡bi
Kvh©µg Aš—f©z³ Kiv cÖ‡qvRb|
†`‡k cÖvqB bZzb †ivM I ¯^v¯ ¨’ mgm¨vi Avwef©ve I cybivwef©ve
j¶Yxq †hgb: Gwfqvb d¬y, †mvqvBb d¬y, †W•¸, wbcv fvBv im BZ¨vw`| G
mKj †iv‡Mi Dci bRi`vwi Ges cÖwZ‡iva e¨e¯ v’ h‡_vchy³ ch©v‡q DbœxZ
Kiv cÖ‡qvRb|
cÖvK…wZK `y‡h©vM Ges Rjevqyi cwieZ©‡bi d‡j m„ó wKQz ¸i“Z¡c~Y© ¯^v¯ ¨’ mgm¨vi g‡a¨ i‡q‡Q k¦vmZš¿ msµvš— e¨vwa, ˆkZ¨ I
Dò cÖevn msµvš— e¨vwa, cvwb evwnZ †ivM, ciRxexevwnZ †ivM †hgb-
g¨v‡jwiqv, †W•¸ BZ¨vw` Ges cywó-nxbZv| ¯^v¯ ¨’ †¶‡Î Ri“wi Ae¯ v’ i
e¨vcv‡i c~e©cÖ¯ w‘ Z MÖnY Ges Rjevqy cwieZ©b †_‡K ¯^v‡¯ ¨’i myi¶v miKv‡ii Rb¨ wekvj P¨v‡jÄ|
cywó-nxbZv msµvš— e¨vwamg~n, Lv`¨ wbivcËv-nxbZv I wek¦ A_©‰bwZK g›`vi Kvi‡Y cywógvb mg„× Lv`¨ MÖn‡Yi nvi K‡g‡Q| Avevi wj½ ˆelg¨ Lv`¨ wbivcËvnxbZvq bZzb gvÎv †hvM Ki‡Q| Mf©eZx gwnjv‡`i g‡a¨ cywó-nxbZvi `i“b Kg IRb wb‡q wkï R‡b¥i nvi
evsjv‡`‡k 43 kZvsk Ges ¯ v’ b I Av_©-mvgvwRK Ae¯’v‡f‡` Mf©eZx
gwnjv‡`i i³¯^íZvi cwigvY 60-80 kZvsk|
kn‡ii ¯^v¯ ¨’ e¨e¯ v’ i Ach©vßZv I †emiKvwi Lv‡Z D”P g~‡j¨i
`i“b kn‡ii cwie RbMY, we‡klZ, ch©vß ¯^v¯’¨‡mev †_‡K ewÂZ n‡”Q|
Awbqwš¿Z bMivqb Av‡iv †ewk ew¯—, RbemwZ, `ye©j evm¯’vb, Ach©vß
cvwb mieivn Ges wbægv‡bi cqtwb®‹vkb e¨e¯ v’ m„wó KiQ ‡ hv RxebaviY
Ges mv‡¯ ¨’ i gvb‡K Zxeªfv‡e cÖfvweZ Ki‡Q| `ª“Z ea©bkxj `wi`ª bMievmxi ¯^v¯ ¨’ Pvwn`v c~iY Kiv miKv‡ii Rb¨ wekvj P¨v‡jÄ wq−p−h cy¡¢s−u−Rz
(T) MÖvgxY ¯^v¯’¨ e¨e¯’v
Dc‡Rjv ¯^v¯ ¨’ e¨e¯’v‡K kw³kvjx Kivi ga¨ w`‡q MÖvg ch©vq ch©š— RbmsL¨v, `vn¨ Ges cywó †mev wbwðZ K‡i Dc‡i ¸i“Z¡ †`qv
n‡e| KwgDwbwU wK¬wbK n‡e ¯^v¯ ¨’ †mevi cÖv_wgK ¯—i| Z…Yg~j ch©v‡q KwgDwbwU wZwb gva¨‡g cÖv_wgK ¯^v¯ ¨’ †mev wbwðZ Kivi cvkvcvwk †idv‡ij e¨e¯ v’ i Dbœqb K‡i Dc‡Rjv I †Rjv ch©v‡q cÖ‡qvRbxq AwaKZi ¯^v¯ ¨’ †mev cÖ`vb wbwðZ Kiv n‡e|
MZ `y'`k‡K evsjv‡`‡k Rb msL¨vZvwË¡K aib Ges Rxebhvcb c×wZ‡Z †ek wKQz cwieZ©b N‡U †M‡Q| Rb e„w×i nvi nªvm† c‡jI †gvU
RbmsL¨v `ª“Z †e‡o Pj‡Q| eq¯‹ RbmsL¨v Ges bMivqb e„wi × mv‡_
evo‡Q †ivM Ges gvbwmK mgm¨v| RxebhvÎvi ixwZ‡Z eo ai‡Yi cwieZ©b G‡m‡Q, †hgb- Pwe©hy³ Lvevi, A¯^v¯’¨Ki Lvevi MÖnY, kvixwiK
cwikª‡gi Afve, we‡bv`b mvgMÖxi Ach©vßZv, Zvgv‡Ki e¨envi, gv`K
Ges cvbx‡qi cÖwZ Avmw³, †ec‡ivqv WªvBwfs, mwnsmZv BZ¨vw` G¸‡jv
bMi GjvKvi wP·K Avg~j e`‡j w`‡”Q| bMivq‡bi d‡j cwih¡l KvVv‡gv‡Z Ges emevm e¨e¯ v’ q cwieZ©b Avm‡Q, hv wkï‡`i I eo‡`i
gvbwmK Ges kvixwiK ¯^v¯’¨ weKvk evavMÖ¯— Ki‡Q|
Avš—R©vwZK gv‡bi Zzjbvq evsjv‡`‡k wPwKrmK, bvm© I cÖhyw³we`‡`i wecyj NvUwZ i‡q‡Q| Gi d‡j RbmsL¨vi GKUv weivU Ask
AÁ I A`¶ †jv‡Ki †mev wb‡Z eva¨ n‡”Q| `¶ gvbe m¤c‡`i msL¨v I
we‡klZt bvm© cÖhyw³we`‡`i msL¨v e„w× Kivi e¨e¯ v’ †bqc v Ö‡qvRb| ¯^v¯ ¨’
Kg©x‡`i †ckvMZ `¶Zv I gvb wbqš¿YKvix ms¯ v’ ¸‡jv‡K AviI Kvh©Ki
f‚wgKv cvjb Ki‡Z n‡e|
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`iKvi|
cÖ`Ë ¯^v¯’¨‡mevi gvb †mevMÖnxZv‡`i mš ó‘ Ki‡Z e¨_© n‡”Q| Gi A‡bK¸‡jv Kvi‡Yi g‡a¨ †mev cÖ`vbKvix I †mevMÖnxZvi g‡a¨ cvi¯cwiK
†evSvcov bv _vKv Ges mn‡R †mev cÖ`vbKvixi Kv‡Q †cŠuQv‡bvi e¨_©Zv
we‡klZ: `wi`ª, cÖvwš—K Ges SzuwKc~Y© Rb‡Mvôxi †¶‡Î| Ab¨vb¨
KviYmg~n n‡jv- †mev cÖ`vbKvix‡`i `¶Zvi Afve Ges cÖ‡qvRbxq hš¿cvwZ, Jla cÎ I †mev cÖ`vbKvixi ¯^íZv|
†emiKvwi ¯^v¯ ¨’ †mev `vbKvix cÖwZôvb I †emiKvwi wPwKrmv wk¶v cÖwZôvbmg~‡ni ¸YMZ gvb wbqš¿Y cÖ‡qvRb| GRb¨ we`g ¨vb ivóªxq wbqš¿Y e¨e¯’v‡K kw³kvjx Kiv cÖ‡qvRb|
miKvwi ¯^v¯ ¨’ AeKvVv‡gvi h_vh_ e¨envi Ges Gi `¶ I djcÖm~
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¯^v¯ ¨’ e¨e¯ v’ I Kg©m~wP, †mev cÖ`vb I `wi`ª-evÜe bxwZgvjv cÖYq‡b ¯^v¯ ¨’ M‡elYv AZ¨š— cÖ‡qvRbxq| M‡elYvjä Z_¨mg~n I cÖgv‡Yi wfwˇZ bxwZ I Kg©m~wP cÖYqb Kiv DËg| ch©vß Rbej, Avw_©K
I cÖvwZôvwbK m¶gZvmn cÖ‡qvMag©x RvZxq ¯^v¯ ¨’ M‡elYv e¨e¯ v’ i Afv‡ei d‡j bxwZ I Kg©m~wP cÖYqb Ges M‡elYvi g‡a¨ †hvMm~Î ¯ v’ cb wewNœZ nq|
¯^v¯ ¨’ †mev e¨e¯ v’ cbv DbœZ Kivi D‡Ï‡k¨ Z_¨ I †hvMv‡hvM cÖhyw³ e¨envi GL‡bv h‡_ó bq| Z_¨ I †hvMv‡hvM cÖhyw³ e¨env‡ii
†¶‡Î wewfbœ ch©v‡qi ¯^v¯ ¨’ Rbkw³i AvMÖn I `¶Zvi Afve Ges cÖ‡qvRbxq AeKvVv‡gvi AcÖZzjZv cÖwZeÜKZv wn‡m‡e weivR Ki‡Q| †ivM ZvwË¡K cwiex¶Y mvg_¨© m‡Ë¡I wbqwgZfv‡e Kiv nq bv| AvPiYMZ cwiex¶‡Yi K_v Lye KgB wPš—v Kiv nq| Z_¨ cÖhyw³i Dbœqb B-‡nj_,
†Uwj †gwWwmb Ges B-Z‡_¨i Rb¨ m¤¢vebvi Øvi D‡b¥vwPZ K‡i‡Q| G¸‡jvi h_vh_ cÖ‡qvM GLbI
nqwb|
`wi`ª, mvgvwRKfv‡e ewÂZ, Awkw¶Z, cÖvwš—K, `~ieZ©x ¯’v‡b emevmiZ gvbyl, Avw`evmx Rb‡Mvôx, bvix, we‡klZt Mf©eZx Ges ¯— b¨`vbKvix, wkï Ges e„× Ges †mB mv‡_ KviLvbv kªwgKiv myweav ewÂZ
n‡”Q| hw`I wKQz Kg©m~wP Zv‡`i Rb¨ ev¯—evqb Kiv n‡”Q, wKš‘ GUv Zv‡`i mvgvwRK Ges mvs¯‹…wZK cwigʇj cÖ‡ek Ki‡Z cvi‡Q bv|
KviLvbv kªwgK, K…wlLvZ, cïcvwL cvj‡b wb‡qvwRZ gvb yl, Avw`evmx, `yM©g Ges `~ieZ©x GjvKvevmx‡`i Rb¨ Ges bvix‡`i mvgvwRK
I cvwievwiK mgm¨v mgvav‡b, mwnsmZvi wei“‡× Ges eq¯‹‡`i Rb¨
wbw`©ó Kg©m~wP MÖnY Kiv cÖ‡qvRb|
(_) wPwKrmv †ckvq ˆbwZKZv
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A_ev wk¶v Ges M‡elYvq ˆbwZKZv wKQz wKQz †¶‡Î weP¨ywZ nq| G msµvš— bxwZgvjv ch©v‡jvPbv Ges hy‡Mvc‡hvMx Kiv cÖ‡qR vb|
(`) RbM‡Yi ¯^v¯ ¨’ m¤§Z Rxebhvcb pwœ²¡¿ ¹Ávb
15 eQ‡ii E‡a© wkw¶‡Zi nvi 60 kZvs‡ki Kg| RbMY GLbI wewfbœ e¨vwa, ¯^v¯’¨ mgm¨v, Acywó Ges my¯^v¯’¨ I ¯^v¯¨ ’m¤§Z Rxebhvcb
m¤c‡K© h‡_ó m‡PZb bq| †ivMx‡K civgk©`vb (Counselling)
Avgv‡`i mgv‡R †ckv wn‡m‡e ¯^xK…Z bq| ¯^v¯ ¨’ m¤c‡K© f A¨vm I `„wófw½i cwieZ©b cÖ‡qvRb| Rxebhvcb c×wZ‡K Av‡iv ¯^v¯¨ ’m¤§Z I Drcv`bkxj Kivi Rb¨ mvgvwRKfv‡e kw³kvjx D‡`¨M MÖnY Ki‡Z n‡e|
Kg©‡KŠkj:
G KvDw݇j miKv‡ii mswk−ó gš¿Yvjq-mn †emiKvwi Lv‡Zi †÷K‡nvìvi I G msµvš— we‡klÁ‡`i Aš—f©z³ Kiv n‡e| KvDwÝj
¯^v¯’¨bxwZ ev¯—evq‡b w`Kwb‡`©kbv cÖ`vb Ki‡e| cÖ‡qvRbxq †¶‡Î ¸i“Z¡c~Y© Ab¨vb¨ wel‡q KvDw݇ji Kv‡Q w`K-wb‡`©kbv PvIqv n‡e|
GKwU wbe©vnx KwgwU MVb Kiv n‡e| GB KwgwU ¯^v¯ ¨’ bxwZ, RbmsL¨v bxwZ
I cywó bxwZi Av‡jv‡K Kg©KvÊ ch©v‡jvPbv Ki‡e| ZvQvov KwgwU cÖ‡qvRbxq AeKvVv‡gv ms¯‹vi, Rbej wb‡qvM, ¯^v¯ ¨’ m¤cwK©Z gvbem¤c`
Dbœqb cwiKíbv I ev¯—evqb, Kg©x‡`i Kg©Rxeb cwiKíbv, Dbœqb,
e¨e¯ v’ cbv bxwZmn ¯^v¯’¨‡mevi mwVK Dbœq‡b civgk© cÖ`vb Ki‡Z cv‡i|
m¤c‡`i cÖvc¨Zvi wfwˇZ KwgwUi mycvwikmg~n ch©vqµ‡g ev¯—evqb Kiv
n‡e|
gš¿Yvjq‡K m¤c„³ K‡i Kg©c×wZ wbe©vPb Kivi e¨e¯ v’ Ki‡Z n‡e|
¯^xK…Z| cÖv_wgK ¯^v¯’¨‡mevi ¸YMZ gvb Dbœqb Ki‡Z n‡eG es Zv
me©Rbxb Kiv n‡e| cÖv_wgK ¯^v¯’¨‡mev msµvš— Kvh©vewj ev¯—evq‡b KwgDwbwU wK¬wbKmg~nB n‡e cÖavb wfwË| KwgDwbwU wK¬wbKmg~‡ni Kg©KvÊ †Rviv‡jv Kiv n‡e Ges ¯ v’ bxq RbMY I ¯ v’ bxq miKvi ms¯v’ ¸‡jvi
Askx`vwi‡Z¡ cwiPvwjZ n‡e| cÖwZ Qq nvRvi gvby‡li Rb¨ GKwU KwgDwbwU wK¬wbK ¯ v’ cb Kiv n‡e| Z‡e we‡kl †fЇMvwjK Ae¯’vb we‡ePbvq A‡c¶vK…Z Kg Rb‡Mvôxi Rb¨I (‡hgb- Pi, nvI oc ,ve©Z¨
AÂj) KwgDwbwU wK¬wbK ¯ v’ cb Kiv †h‡Z cv‡i| `ª“Z bMivq‡bi d‡j
kniv‡j †gvU RbmsL¨vi mv‡_ mv‡_ `wi`ª gvby‡li msL¨v evo‡Q|
we`¨gvb ¯^v¯’¨‡mev e¨e¯ v’ cÖ‡qvR‡bi Zzjbvq AcÖZzj| G‡`i Rb¨ cÖ‡qvRbxq cwievi cwiKíbv I ¯^v¯’¨‡mev wbwðZ Kiv n‡e| Kvh©Ki
†idv‡ij c×wZi gva¨‡g kni I MÖvg Dfq †¶‡ÎB RwUjZi †ivMx‡`i
cieZ©x av‡c wPwKrmvi e¨e¯ v’ Kiv n‡e|
wPwKrmvi e¨e¯ v’ Kiv n‡e|
cÖwZ‡iva I ¯^v¯ ¨’ m‡PZbZv e„w×i Rb¨ we‡kl ¸i“Z¡ †`q vn‡e| Av‡ivM¨g~jK I cybe©vmb †mev¸‡jvi m‡š—vlRbK cÖ‡qvM wbwðZ Kiv
n‡e|
c×wZ‡K we¯—…Z K‡i †ivM wbqš¿Y Kg©m~wPi m‡½ mgwš^Z Ki ‡n Z‡e|
Jla bxwZ‡K AviI MÖnY‡hvM¨ Ges DbœZ Ki‡Z n‡e| eZ©gvb mg‡qi Pvwn`v, wbivcËv, DcKvwiZv, µq ¶gZvi w`‡K j¶¨ †i‡L me©¯—‡i
Ri“wi Jla mnRcÖvc¨Zv wbwðZ Kiv n‡e|
Drcv`b, mnRcÖvc¨Zv I mieivn wbwðZ Kiv n‡e|
cywó, ¯^v¯ ¨’ I cwievi cwiKíbv wk¶vi Dci we‡kl ¸i“Z¡ w`‡Z n‡e|
cÖ‡Z¨K Dc‡Rjvq GKwU cywó Ges GKwU ¯^v¯ ¨’ wk¶v BDwbU _vK‡e|
G¸‡jvi Kg©KvÊ cÖZ¨š— AÂj ch©š— ch©vqµ‡g we¯—…Z Kin v ‡e| ¯^v¯’¨‡mevi m‡½ mgwš^Z fv‡e Dc‡Rjv ch©š— ¯^v¯’¨ wk¶vi e¨e¯’v Kiv
n‡e|
kvixwiK, gvbwmK ¯^v‡¯ ¨’ i Dci bvixi AwaKvi wbwðZ Kiv n‡e| gvZ… g„Z¨y
I GK eQ‡ii Kg eqmx wkï g„Z¨yi nvi Kgv‡bvi Dci †Rvi` w‡q bvixi
Rb¨ cÖv_wgK ¯^v¯’¨‡mev †Rvi`vi Kiv n‡e| bvix‡`i we‡klZ: Mf©eZx
gwnjv‡`i cywó Pvwn`v c~iY Kiv n‡e| m‡PZbZv e„w×i gva‡g ¨ bvix‡`i GBPAvBwf/GBWm Ges Ab¨vb¨ †hŠb‡ivM n‡Z i¶vi c`‡¶c MÖnY Ki‡Z
n‡e| mKj ¯^v¯ ¨’ cÖwZôv‡b bvix evÜe KvVv‡gv ˆZwi Ki‡Z n‡e|
Rb¨ cÖRbb ¯^v¯’¨ GKwU ¸i“Z¡c~Y© Dcv`vb| MÖvg I kni GjvKvq cÖvwš—
K gvby‡li Kv‡Q Gme †mev AviI e¨vcKfv‡e †cŠu‡Q †`qn v‡ e| mvaviY
¯^v¯ ¨’ †mev I cÖRbb ¯^v¯ ¨’ †mev mgwš^Zfv‡e w`‡j Zv Rb-evÜe I e¨q
mvkªqx n‡e| ¯^v¯ ¨’ I cwievi Kj¨vY Kg©m~wP Kvh©Ki fv‡e mgš^q Kiv
n‡e|
Management Information System) Ges Kw¤cDUvi wbf©i †hvMv‡hvM
e¨e¯ v’ mviv‡`‡k cÖwZôv Kiv n‡e, hv Kg©m~wP ev¯—evqb, Kg© cwiKíbv
cÖYqb Ges gwbUwis-Gi Rb¨ mnvqK wn‡m‡e KvR Ki‡e|
Rb¨ bxwZgvjv ev AvBb cÖYqb Kiv n‡e|
cÖkvmwbK wel‡qi Dci wPwKrmKmn ¯^v¯ ¨’ Lv‡Z wb‡qvwRZ Ab¨vb¨‡`i cÖwk¶‡Yi Rb¨ we`¨gvb cÖwZôvbmg~n‡K Av‡iv AvaywbK I hy‡Mvc‡hvMx
Kiv n‡e|
f‚wgKv cvj‡b DrmvwnZ Kiv n‡e| †emiKvwi Lv‡Z ¯^v¯ ¨’† mev I wPwKrmv
e¨e¯ v’ †ivMx‡`i mwVK I gvb m¤cbœ wPwKrmv †mev cÖvwß wbwðZ Kivi Rb¨ cÖ‡qvRbxq wewa-weavb ˆZwi Kiv I cÖ‡qvM Kivi e¨e¯ v’ Kiv n‡e| cix¶v-
wbix¶vmn Ab¨vb¨ wPwKrmv e¨q mnbxq ch©v‡q ivLvi e¨e¯v’ †bqv n‡e|
eivÏ evov‡bv n‡e| Rb¯^v¯ ¨’ , ¯^v¯’¨ e¨e¯’vcbv I bxwZ, mvgvwRK I
AvPiYMZ Ges cÖv‡qvwMK M‡elYvi Dci †Rvi †`qv n‡e| evsjv‡`‡k †h
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n‡e| Rjevqy cwieZ©‡bi d‡j m„ó †ivM¸‡jvi †evSv Kgv‡Z GKwU RvZxq Kg©m~wP MÖnY Kiv n‡e|
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m¤cÖmvwiZ Kiv n‡e| GRb¨ `¶ Rbej ˆZwi I M‡elYvi wel‡q ¸i“Z¡
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1| f ÐÙ¹¡he¡
K‡i‡Q| Jla Drcv`‡bi cÖ‡qvRbxq cÖhyw³ AR©b Kivq evsjv‡`‡ki Jlawkí eZ©gv‡b cÖPwjZ I DbœZ cÖhyw³-wbf©i cÖvq me ai‡bi †Wv‡mR& dg©B Drcv`‡b m¶g| †`‡k Jla Drcv`‡bi DbœZ cÖhyw³i cvkvcvwk i‡q‡Q AwfÁ I `¶ dvg©vwm÷mn Ab¨vb¨ mswk−ó `¶ Rbkw³| 2009 mvj †_‡K ¯^v¯ ¨’ †mev‡K›`ª/ myweav m¤úªmvi‡Yi cvkvcvwk ¸YMZgvbm¤úbœ ch©vß cwigv‡Y Jla mieivn Kiv n‡”Q|
wek¦ evwYR¨ ms¯ v’ i Ô†gav¯^Z¡ I evwYR¨ AvBbÕ ev wUªcm& (Trade Related Aspects of Intellectual Property Rights - TRIPS) Pzw³i Av‡jv‡K evsjv‡`‡ki Jla †m±i‡K cÖ¯ Z‘ Kiv cÖ‡qvRb| eZ©gvb miKvi wbe©vPbx Bk‡Znv‡ii cÖwZkª“wZ †gvZv‡eK miKvi MV‡bi ïi“‡Z RvZxq ¯^v¯’¨ bxwZ, RvZxq RbmsL¨v bxwZ Ges RvZxq JlabxwZ cÖYq‡b nvZ †`b| RvZxq ¯^v¯’¨ bxwZ, 2011, RvZxq RbmsL¨v bxwZ, 2012 Gi mv‡_ mvgÄm¨
†i‡L RvZxq JlabxwZ, 2016 cÖYqb Kiv n‡q‡Q|
I mgv`„Z nq| G JlabxwZi d‡j evsjv‡`‡ki Ily‡ai wbivcËv wbwðZ nq
I gvb DbœZ nq, Ily‡ai `v‡gi Ici wbqš¿Y cÖwZwôZ nq| Avg`vwb wbf©iZv K‡g †`k Ily‡ai †¶‡Î ¯^wbf©i n‡Z ïi“ K‡i, Jla †m±‡i we‡`wk AvwacZ¨ K‡g Av‡m, †`kxq Jla †Kv¤úvwbmg~n AvaywbK cÖhyw³mg„× e„n`vKvi KviLvbv ¯ v’ cb Ki‡Z _v‡K| Avš—R©vwZK cwigÛ‡j evsjv‡`‡ki
Jla †m±‡ii fveg~wZ© D¾¡j nq Ges GK mgqKvi Jla Avg`vwbKvix †`kwU Jla ißvwbKvix †`‡k cwiYZ nq|
wKQz D‡`¨vM wQj, wKš‘ G‡Z JlabxwZi CwáZ j¶¨mg~n AwRZ © nqwb| RbM‡Yi ¯^v_©i¶vi cvkvcvwk evsjv‡`‡ki Jla wk‡íi Rb¨ †`‡k Ges
†`‡ki evB‡i m¤¢vebvi †h †¶Î¸‡jv ˆZwi n‡q‡Q †m cÖZ¨vkv¸‡jv aviY
K‡i miKvi KZ…©K mg‡qvc‡hvMx Z…Zxq GKwU RvZxq JlaZ bx wcÖYqb Kiv Avek¨K n‡q c‡o‡Q| G j‡¶¨ †`‡ki Jlawkí‡K AviI `vwqZ¡kxj n‡q
Jl‡ai Drcv`b I gvb-wbqš¿‡Y wek¦ ¯^v¯’¨ ms¯’v wb‡`©wkZ wRGgwc bxwZgvjv K‡Vvifv‡e †g‡b Pjvi Dc‡hvMx n‡Z n‡e|
†nvwgIc¨vw_K I ev‡qv‡KwgK c×wZi †`kR m¤ú`-wbf©i Gme wkí Zv‡`i wbR¯^ †gŠwjK bxwZ I wek¦ ¯^v¯’¨ ms¯’vi GMP Guideline AbymiY K‡i mdjZvi mv‡_ Jla Drcv`‡bi †Póv Ki‡Q| UªvwWkbvj wP Krmv c×wZi cÖwZ RbM‡Yi A‡bKvs‡ki AvMÖn Ges UªvwWkbvj wPwKrmv c×wZ‡K RvZxq ¯^v¯ ¨’ †mevq Kvh©Kifv‡e Aš—fz©³ Kivi Rb¨ wek¦ ¯^v¯’¨ ms¯’vi mycvwikgvjvi Av‡jv‡K AvaywbK wPwKrmv c×wZi cvkvcvwk Avqy‡e©w`K, BDbvbx, nve©vj, †nvwgIc¨vw_K I ev‡qv‡KwgK Jlawkí‡KI GwM‡q Avmvi my‡hvM †`Iqv cÖ‡qvRb| RvZxq ¯^v¯ ¨’ bxwZ, 2011 G weKí wPwKrmv c×wZi Dci ¸i“Z¡ cÖ`vb Kiv n‡q‡Q|
2| RvZxq JlabxwZi j¶¨mg~n
2.1| RbMY hv‡Z wbivc`, Kvh©Ki I gvbm¤úbœ Jla n‡R µqmva¨ g~‡j¨ †c‡Z
cv‡i Zv wbwðZ Kiv|
2.2| Jl‡ai †hŠw³K I wbivc` e¨envi Ges myôz cwi‡ekb ¨ ee¯ v’
(Dispensing) wbwðZ Kiv|
2.3| ¯ v’ bxq mKj c×wZi Jla cÖ¯ Z‘ Kvix wkímg~n‡K AMÖvwaKvi wfwˇZ
cÖ‡qvRbxq †mev I my‡hvM-myweav cÖ`vb Kiv, hv‡Z gvbm¤úœ bJla I Jl‡ai KuvPvgvj Drcv`‡bi †¶‡Î ¯^qsm¤ú~Y©Zv AwR©Z nq|
2.4| †`‡ki Drcvw`Z Jl‡ai ißvwb e„w× Kiv|
2.5| Jl‡ai Kvh©Ki bRi`vix (Surveillance) e¨e¯’v cÖwZôv Kiv|
3| RvZxq JlabxwZi Dcv`vbmg~n
3.1| Jl‡ai wbivc` e¨envi, Kvh©KvwiZv Ges Dc‡hv MZv wbwðZ Kivi j‡¶¨
DbœZ †`‡ki wbeÜb gvb`‡Ûi mv‡_ m½wZ †i‡L wbeÜb cÖwµqv mgq mgq nvjbvMv` Kiv|
3.2| Jla cÖkvmb Awa`߇ii eZ©gvb Rbkw³ I AeKvVv‡gvMZ my‡hvM-myweav
h_vh_fv‡e e„w×i gva¨‡g G‡K RvZxq Jla wbqš¿Y KZ…©cN ¶a (tional Regulatory Authority-NRA) wn‡m‡e Kvh©Ki Kivi Rb¨ Jla cÖkvmb Awa`ßi‡K AviI kw³kvjx Kiv| RvZxq Jla wbqš¿YKvix KZ…¶ ©c‡K b~¨bZg WHO (World Health Organisation)-Gi ¯^xK…wZ Ges PIC/s The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co operation Scheme)-Gi
m`m¨fz³ Kiv|
3.3| bKj, †fRvj, ¶wZKi, wbeÜbwenxb, KvD›Uvi‡dBU (counterfeit),
wgmeªv‡ÛW (misbranded) I wb¤œgv‡bi Jla I †gwW‡Kj wWfvBm cÖ¯ Z‘ , weµq I weZiY wbwl× Kiv Ges Abyiƒc Kg©Kv‡Ûi Rb¨ `vqx e¨w³‡`i `„óvš—g~jK kvw¯— cÖ`vb Kiv|
3.4| Jla wbe©vPb, cwigvY wba©viY, msMÖn, gRy`KiY I weZiY c×wZ †Rvi`vi
Kiv, hv‡Z †`‡ki mKj GjvKvq RbM‡Yi Kv‡Q †m¸‡jv mnRjf¨ nq|
Jl‡ai cvBKvwi †`vKvb ev dv‡g©mxmn mKj ai‡bi Jl‡ai msi¶YvMv‡i ev cwienb I weZiYKv‡j Jl‡ai gvb Ges myôz cª‡qvM I cwi‡ekb e¨e¯ v’ (Dispensing) eRvq ivLvi Rb¨ ZvcgvÎv I Av`ª©Zv wbqš¿Ymn h_vh_ msi¶Y c×wZ wbwðZ Kiv|
3.5| me ¯^xK…Z c×wZi Jl‡ai †hŠw³K, Kvh©Ki I wbivc` e¨envi wbwðZ Kivi
j‡¶¨ MYgva¨‡g Jl‡ai mKj iKg weÁvcb I cÖPvi wbqš¿Y Ges A‰bwZK wecYb (Unethical Marketing) wKsev eû¯—i wecYb‡iv‡a (Multi Level Marketing) myôz bxwZgvjv cÖYqb I cÖ‡qvM Kiv|
3.6| myjf g~‡j¨ Jl‡ai mnRjf¨Zv wbwðZ Kiv Ges ¯^”Q I h †Šw³Kfv‡e Jl‡ai
g~j¨ wba©viY Kiv| miKvi KZ…©K mg‡q mg‡q ZvwjKvfz³l a Jmg~‡ni g~j¨ wba©viY/ cybtwba©viY c×wZ Ae¨vnZ ivLv|
3.7| †`‡k bZzb cÖhyw³ I KvwiMwi Ávb n¯—vš—‡ii j‡¶¨ be-Avwe®‹…Z A_ev D”P
cÖhyw³i (†hgb-ev‡qv‡UK‡bvjwR) Jl‡ai †¶‡Î †`‡k wewb‡qvM, Jla Drcv`b I evRviRv‡Zi Rb¨ M‡elYvwfwËK we‡`wk Jla Drcv`bKvix cÖwZôvb¸‡jv‡K DrmvwnZ Kiv| †`‡k bZzb cÖhyw³ I KvwiMwi Ávb n¯—vš—
‡ii h_vh_ wbðqZvmn evsjv‡`‡k wewb‡qvM, Jla Drcv`b I weµ‡qi Rb¨ M‡elYvwfwËK Jla cÖ¯ Z‘ KviKMY‡K DrmvwnZ Kiv|
3.8| Jla Drcv`bKvix‡`i‡K wbR wbR cÖwZôv‡b Kvh©Ki M‡elYv I Dbœq‡b
(Research & Development, R & D) DØy× Kiv| G mKj M‡elYvMv‡ii Rb¨ Avg`vwbK…Z hš¿cvwZi Dci Av‡ivwcZ ïn évi Kgv‡bv, †mB mv‡_ wek¦we`¨vjq, m¶g M‡elYv ms¯ v’ I Jla Drcv`bKvix‡`i mgwš^Z †hŠ_ D‡`¨v‡M cÖv‡qvwMZ M‡elYv (Applied Research) Drmvn †`Iqv| Jla msµvš— †gŠwjK I dwjZ M‡elYv (Basic and Applied
Research) Kvh©µg MÖn‡Yi Rb¨ miKvi, wek¦we`¨vjq, M‡elYv Bbw÷wUDU, mswk−ó †ckvRxex Ges cÖ¯ Z‘ KviKM‡Yi g‡a¨ mn‡hvwMZv‡K DrmvwnZ Kiv|
3.9| Jl‡ai weiƒc cÖwZwµqvi NUbvmg~n h_vh_fv‡e AewnZ Kivi Rb¨ mswk−ó
mKj‡K DØy× Kivi gva¨‡g dvg©v‡KvwfwR‡jÝ (Pharmacovigilance) Ges Jl‡ai weiƒc cÖwZwµqvmg~‡ni A (dverse Drug Reactions - ADR) Dchy³ cwiex¶Y wbwðZ Kiv|
3.10| Jla Drcv`bKvix me ¯^xK…Z c×wZi KviLvbvmg~‡n hv _h_fv‡e Good
Manufacturing Practices (GMP) AbymiY I ev¯—evq‡bi j‡¶¨ Drcv`bKvix cÖwZôv‡b mswk−ó †ckvq `¶ Rbej wb‡qvM I wbqwgZ cÖwk¶Y wbwðZ Kiv|
3.11| †`‡k Drcvw`Z Jl‡ai ißvwb e„w× Kivi Rb¨ miKvw ich©v‡q cª‡qvRbxq e¨e¯’v
MÖnY Ges wewfbœ cÖ‡Yv`bv cÖ`vb Kiv|
3.12| (K) Jl‡ai cix¶v I we‡k−l‡Yi Rb¨ †K›`ªxq cix¶vMvi wn‡m‡e National
Control Laborotory (NCL)-†K AvaywbKxKiY I ch©vqµ‡g me wefv‡M †K›`ªxq cix¶vMv‡ii (Drug Testing Laboratory) kvLv ¯’vc‡bi e¨e¯’v
Kiv Ges †K›`ªxqfv‡e GKwU ¯^vqËkvwmZ RvZxq †idv‡iÝ cix¶vMvi cÖwZôv
Kiv| BDbvbx, Avqy‡e©w`K, nve©vj I †nvwgIc¨vw_K-ev‡qv‡KwgK Jlamg~‡ni
Rb¨ we‡klvwqZ AvaywbK cix¶vMvi ¯ v’ cb Kiv|
(L) m¶g M‡elYv ms¯ v’ wn‡m‡e AvaywbK I UªvwWkbvj Jl‡ai cix¶v, we‡k−lY I †idv‡iÝ cix¶vMv‡ii Kv‡Ri mv‡_ wewmGmAvBAvi (Bangladesh Council of Scientific and Industrial Research-BCSIR)-†K m¤ú„³ Kiv|
(M) cix¶v I we‡k−l‡Yi Rb¨ miKvwi, †emiKvwi I ¯^vqËkvwmZ ch©v‡q cÖwZwôZ †Kvb M‡elYv cÖwZôvb‡K Third Party Quality Evaluator Gi Av`‡j ¯^xK…wZ †`Iqv|
3.13| †`‡ki Rb¯^v¯ ¨’ i¶vK‡í A¨v‡jvc¨vw_K, Avqy‡e©w`K, BDbvbx, nve©vj
I †nvwgIc¨vw_K Jl‡ai Rb¨ Avjv`v Avjv`v AZ¨vek¨Kxq Jl‡ai ZvwjKv cÖYqb Kiv|
3.14| Jl‡ai †hŠw³K e¨envi wbwðZ Kivi j‡¶¨ †iwR÷vW© wPwKrm‡Ki e¨e¯ v’ cÎ
Qvov Jla weµq I weZiY wbwl× Kiv|
3.15| DbœZ †`kmg~‡ni Av`‡j mvaviYfv‡e e¨env‡ii †ÿ‡ Îe¨e¯ v’ cÎ-wenxb
wbivc` Jl‡ai (Over-the-Counter-OTC) ZvwjKv cÖKvk Kiv|
3.16| Avqy‡e©w`K, BDbvbx, nve©vj, †nvwgIc¨vw_K I e‡ vqv‡KwgK Jl‡ai gvb
Dbœq‡bi j‡¶¨ G¸‡jvi Drcv`b e¨e¯’vq ˆeÁvwbK cÖhyw³-wbf©i gvb-wbqš¿Y e¨e¯’v AšÍfz©³ Kiv|
3.17| Jlwa¸Ym¤úbœ, dvg©vwmDwUK¨vj †Wv‡Rm& d‡g© Drcvw`Z I †ivM wbivg‡q
wb‡`©kK…Z cY¨‡K Jla wn‡m‡e MY¨ Kiv Ges G j‡¶¨ cÖ‡qvRbxq wbqš¿Y wbwðZ Kiv| †h mKj cÖmvabx-RvZxq cY¨ kvixwiK †Kvb Kvh©µ‡gi cwieZ©b K‡i _v‡K, †m¸‡jv‡K Jla cªkvmb Awa`߇ii wbqš¿‡Y Avbv|
3.18| †gwWK¨vj wWfvBm I mvwR©K¨vj BKzBc‡g›U hv gvbe kix‡ii ms¯ú‡k© Av‡m,
†m¸‡jv‡K Jla cÖkvmb Awa`߇ii wbqš¿‡Y Avbv|
3.19| miKvwi I †emiKvwi ch©v‡q mswk−ó †ckvi `¶ I cw Ökw¶Z Rbe‡ji
gva¨‡g Jl‡ai wK¬wbK¨vj Uªvqvj (Clinical Trial) I ev‡qvBKzf¨v‡jÝ cix¶Y (Bioequivalence Study) myweav m„wó Kiv|
3.20| WTO/TRIPS Pzw³i Av‡jv‡K evsjv‡`‡ki Jla wkí weKv‡k mnvqZv Kiv|
3.21| Jl‡ai cvkvcvwk wewfbœ ai‡bi Lv`¨ mvgMÖxi ¸Yv¸Y I wbivcËv
wbwðZK‡í eZ©gvb ÔJla cÖkvmb Awa`ßiÕ‡K (Directorate General of Drug Administration) ÔLv`¨ I Jla cÖkvmb Awa`ßiÕ (Directorate General of Food and Drug Administration)-G iƒcvšÍi Kiv Ges Gme mvgMÖxi Ici AvBwb wbqš¿Y cÖwZôvi j‡¶¨ Gi Kg©c iwa I mvsMVwbK KvVv‡gv cybwe©b¨vm Kiv|
4| RvZxq Jla bxwZi AvIZvfz³ welqvw`
4.1| we`¨gvb AvBb I wewagvjvi cª‡qvM Ges ms‡kvab
weZiY, msi¶Y, Avg`vwb, ißvwb wbqš¿Y Ges bRi`vixi †¶‡Î we`¨gvb †ek wKQz bxwZ, AvBb I mswk−ó wewagvjv AcÖZzj I m½wZnxb n‡q c‡o‡Q| cwiewZ©Z †cÖ¶vc‡U we`¨gvb Gme AvBb I wewagvjv‡K hy‡Mvc‡hvMx I Kvh©Ki Ki‡Z G¸‡jv cÖ‡qvRbgZ ms‡kvab Kiv Avek¨K|
AvBb, 1940 (Drug Act, 1940) Ges Jla (wbqš¿Y) Aa¨v‡`k
1982 [Drug (Control) Ordinance 1982] mgš^‡q evsjvq hy‡Mvc‡hvMx nvjbvMv`K…Z GKwU AvBb Ges Dwj−wLZ AvBbmg~n ev¯Íevq‡bi j‡¶¨ cÖ‡qvRbxq WªvM i“jmg~n (Drug Rules)
h_vkxNª cÖYqb Kiv n‡e|
G wel‡q †fv³vi AwaKvi cÖwZôv we`¨gvb AvB‡bi weavbmg~n h_vh_ cÖ‡qvM wbwðZ Kiv n‡e|
4.2| Kvh©Ki, wbivc` I gvbm¤úbœ Jl‡ai mnRjf¨Zv
GBWm& (AIDS) I †W½ymn Ab¨vb¨ msµvgK e¨vwa cÖwZ‡iva I wbg~©jKi‡Yi j‡¶¨ mswk−ó Jl‡ai mnRjf¨Zv wbwðZ Kiv n‡e|
4.3| Jl‡ai †hŠw³K I wbivc` e¨envi
Jla wbqš¿Y KZ…©c‡¶i Aby‡gv`b mv‡c‡¶ Ôevsjv‡`k b¨vj k bv dgy©jvwiÕ ev wewWGbGd (Bangladesh National Formulary-BDNF) wbqwgZfv‡e nvjbvMv` I I‡qe mvB‡U
cÖKvk Kiv n‡e| GKBfv‡e Jla wbqš¿Y KZ…©c‡¶i Aby‡gv`b mv‡c‡¶ Ôevsjv‡`k RvZxq Avqy‡e©w`K dgy©jvwiÕ, Ôevsjv` ‡k RvZxq
BDbvbx dgy©jvwiÕ, Ôevsjv‡`k RvZxq nve©vj dgy©jvwiÕ Ges Ôevsjv‡`k †nvwgIc¨vw_K dvg©v‡KvwcqvÕ wbqwgZ cÖYqb, nvjbvMv` I
I‡qe mvB‡U cÖKvk Kiv n‡e|
Gi cÖZ¨¶ ZË¡veav‡b ÔnmwcUvj dv‡g©mxÕ (Hospital Pharmacy) Kvh©µg cwiPvjbvi cÖ‡qvRbxq e¨e¯ v’ MÖnY Kiv n‡e| Jl‡ai †hŠw³K e¨envi wbwðZ Kivi j‡¶¨ cÖwZwU nvmcvZv‡ji wbR¯^ Jla wb‡`©wkKv (dgy©jvix) cÖYqb, wbqwgZ nvjbvMv` I I‡qe mvB‡U cÖKvk Kiv n‡e|
4.4| Jl‡ai wbeÜb
1| mKj Jla hv †`‡k wewfbœ †Wv‡Rm d‡g© Drcv`b, Avg`vwb, weZiY I
wecYb ev e¨envi nq Zv Aek¨B Jla wbqš¿Y KwgwUi (Drug Control Committee-DCC) mycvwi‡ki wfwˇZ WªvM
jvB‡mwÝs KZ…©c¶ Øviv wbewÜZ n‡Z n‡e| Rxeb i¶vKvix Z bzb Jla RbM‡Yi Rb¨ `ª“Z mnRjf¨ Kivi D‡Ï‡k¨ wbqwgZ Jla wbqš¿Y KwgwUi mfv AbywôZ n‡e|
2| Jla wbqš¿Y KwgwUi KvR n‡e ¯ v’ bxqfv‡e Drcv`b A_ev
Avg`vwbi wbwg‡Ë Av‡ew`Z mKj Jla I †gwW‡Kj wWfvBm- Gi wbivcËv, Kvh©KvwiZv Ges Dc‡hvwMZv (Safety, efficacy and usefulness) g~j¨vq‡bi gva¨‡g wbe܇bi
Rb¨ gZvgZ ev mycvwik cª`vb Kiv| G D‡Ï‡k¨ mswk−ó we‡klÁ I †ckvRxexi mgš^‡q Jla wbqš¿Y KwgwU MwVZ n‡e|
1| cÖwZwôZ wb‡`©kbv Abyhvqx Jl‡ai wbeÜb cÖ`vb Kiv n‡e| Jla
wbqš¿Y KwgwUi mycvwik e¨wZ‡i‡K †Kvb Jl‡ai bZzb wb‡`©kbv Aby‡gv`b Kiv hv‡e bv|
2| cÖ‡qvRbxq AeKvVv‡gv Ges gvb wbwðZKiY e¨e¯ v’ (Quality
Assurance Management) e¨ZxZ †Kvb cªwZôvb‡K
Jla Drcv`‡bi AbygwZ †`Iqv n‡e bv| D”P cÖhyw³i †Kv‡bv
Jla ev m¤ú~Y© Avjv`v KvVv‡gv I my‡hvM-myweavw`i (Dedicated) cÖ‡qvRb nq Ggb Jla wek¦ ¯^v¯’¨ ms¯’vi wRGgwc MvBW jvBb Abyhvqx Drcv`‡bi cª‡qvRbxq KvVv‡gv e¨ZxZ wbeÜb †`Iqv n‡e bv| D‡j−L¨ †h, B‡Zvg‡a¨ †hme
Jla wbeÜb †`Iqv n‡q‡Q Zv cybtg~j¨vqbc~e©K ïaygvÎ †hvM¨Zvm¤úbœ cÖwZôvb‡K Drcv`‡bi AbygwZ †`Iqv n‡e|
3| wPwKrmvq AZ¨vek¨Kxq cÖZxqgvb bv n‡j
wgkÖYRvZxq (Combination) A¨v‡jvc¨vw_K Jl‡ai wbeÜb mvaviYfv‡e wbi“rmvwnZ Kiv n‡e| mswk−ó Combination Product Gi †¶‡Î Ace¨env‡ii m¤¢vebv ¸i“‡Z¡i mv‡_ we‡ePbvq ivL‡Z n‡e| A¨v‡jvc¨vw_K Jl‡ai †iwR‡÷ªkb cÖ`v‡bi †¶‡Î United States Food &
Drug Administration (US-FDA) ev The Medicines & Healthcare Products Regulatory
Agency (MHRA) KZ…©K Aby‡gv`‡bi ev British
National Formulary (BNF) G AšÍf©yw³i Z_¨vw` AbymiY Ki‡Z n‡e| cÖPwjZ Combination Product-
mg~‡ni wbeÜb cÖ‡qvRb Abyhvqx cybg©~j¨vqb Kiv n‡e|
4| BDbvbx, Avqy‡e©w`K, nvev©j I †nvwgIc¨vw_K-ev‡qv‡KwgK
Jlamg~n Jla wbqš¿Y KwgwUi mycvwi‡ki wfwˇZ WªvM jvB‡mwÝs KZ…©c¶ Øviv wbewÜZ n‡Z n‡e| †KejgvÎ BDbvbx, Avqy‡e©w`K I †nvwgIc¨vw_K dg©yjvwi/dvg©v‡Kwc vqvi AšÍf©y³ Jlamg~‡ni wbeÜb we‡ePbv Kiv n‡e|
5| gv`viwUsPvi, A‡kvwaZ UªvBUz¨‡ikb I 12wU ev‡qv‡Kg w Jl‡ai 1⋅ c‡UÝxi Rb¨ wbe܇bi cÖ‡qvRb n‡e, wKš‘
†nvwgIc¨vw_K I ev‡qv‡Kwg Jlamg~‡ni c‡UÝx AviI e„i w ×
Rb¨ †Kvb wbe܇bi cÖ‡qvRb n‡e bv|
6| †nvwgIc¨vw_K dvg©v‡Kvwcqv Abyhvqx Zij Jla KwVb evnK, h_v
j¨vK‡UvR/ †M−vweDjm BZ¨vw` Ges KwVb Jla Zij evnK, h_v weï× cvwb/A¨vj‡Kvnj BZ¨vw` mn‡hv‡M mswgkÖY/iƒcvšÍi K‡i †meb‡hvM¨| G‡¶‡Î Zij n‡Z KwVb AvKvi (dg©) ev KwVb n‡Z Zij AvKv‡i iƒcvšÍ‡ii gva¨‡g kw³K…Z Jl‡ai wbe܇bi cÖ‡qvRb n‡e bv|
1| we‡`‡k Drcvw`Z I evsjv‡`‡k wbewÜZ Jla, jvB‡mwÝs
KZ…©c‡¶i AbygwZ mv‡c‡¶ Avg`vwb Kiv hv‡e| Avg`vwbK…Z
Jl‡ai †iwR‡÷ªk‡bi Rb¨ Bioequivalence Study I
Clinical Trial msµvšÍ Z_¨vw` `vwLj Ki‡Z n‡e| Avg`vwbi Rb¨ wbe܇bi †¶‡Î be-Avwe®‹„Z Rxeb i¶vKvix Jlamg~n‡K AMÖvwaKvi cÖ`vb Kiv n‡e|
mswk−ó Jla GKB cY¨bv‡g wb¤œewY©Z Kgc‡¶ GKwU DbœZ †`‡k evRviRvZKi‡Yi Rb¨ wbewÜZ n‡Z n‡e : hy³ivóª, hy³ivR¨, Rvg©vwb, d«vÝ, myBRvij¨vÛ, Rvcvb I A‡÷ªwjqv|
Z‡e D³ Avg`vbx‡hvM¨ Jla Avwe®‹viK †Kv¤úvbxi g~j Drcv`b KviLvbv (Original Manufacturing Site)
A_ev DcwiD³ †h †Kvb GKwU †`‡k Aew¯’Z Drcv`b KviLvbv †_‡K msM„nxZ n‡Z n‡e|
2| cÖvwYm¤ú` I grm¨ wPwKrmvi Jl‡ai Avg`vwb †iwR‡÷ªk‡bi
†¶‡Î D³ Jla evRviRvZKi‡Yi D‡Ï‡k¨ Drm †`k Ges BD‡ivcxq BDwbqbfz³ †`k Ges hy³ivóª, myBRvij¨vÛ, KvbvWv, A‡÷ªwjqv, Rvcvb, `w¶Y †Kvwiqv I wm½vcyi Gi AšÍZt GKwU †`‡ki wd« †mj mvwU©wd‡KU (Free Sale Certificate) `vwLj Ki‡Z n‡e| D‡j−L¨ †h, D³ Jla ZvwjKvfz³ †`k ev †`kmg~‡n GKB eªvÛ bv‡g weµ‡qi Rb¨ wbewÜZ _vK‡Z n‡e|
3| Avg`vwbK…Z Jla I KuvPvgvjmg~n h_vh_fv‡e wRGgwc
Abymi‡Y Drcvw`Z nq wKbv †m wel‡q wbwðZ nIqvi j‡¶¨ cÖZ¨qbcÎ `vwL‡ji e¨e¯ v’ mn cÖ‡qvRb‡ev‡a RvZxq Jla wbqš¿YKvix KZ…©c‡¶i c¶ †_‡K Drcv`bKvix cÖwZôvb cwi`k©b Kiv n‡e| GMP MvBWjvBb Ges cÖYxZ Check
List Gi Av‡jv‡K ißvwbKviK †`‡ki Jla KviLvbv Validation Certification Kiv n‡e|
4| nvev©j I †nvwgIc¨vw_K-ev‡qv‡KwgK Jlamg~n Jla wbqš¿Y
KwgwUi mycvwi‡ki wfwˇZ Jla cÖkvmb Awa`ßi KZ…©K Avg`vwbi D‡Ï‡k¨ wbewÜZ n‡Z n‡e| †`kxq †flR n‡Z D™¢~Z nIqvq BDbvbx I Avqy‡e©w`K Jla Avg`vbxi Rb¨ we‡ePbv Kiv n‡e bv, Z‡e BDbvbx I Avqy‡e©w`K Jl‡aig ‡a¨
†h mKj AZ¨vek¨Kxq Jla hv †`‡k Drcvw`Z nq bv †m¸‡jv Avg`vbxi my‡hvM ivLv †h‡Z cv‡i|
5| ÁvZ ¸i“Zi cvk¦© cÖwZwµqv nIqvi m¤¢vebv _vKv m‡Ë¡I weKí
Jla bv cvIqv †M‡j wbw`©ó wKQz Jla wbqwš¿Z e¨env‡ii D‡Ï‡k¨ mxwgZ cwigv‡Y Avg`vwbi Aby‡gv`b †`Iqv †h‡Z cv‡i|
¯’vcbv/ †cÖwg‡mm, BDwUwjwU/mvwf©‡mm, ¯ v’ wcZ †gwkbvwi/BKzBc‡g›U, Drcvw`Z Jl‡ai †_ivwcDwUK †kÖYx Ges †Wv‡Rm dg© BZ¨vw` we‡ePbv K‡i Zv‡`i‡K Jla Drcv`‡bi mvg_©¨ Abyhvqx †kÖYxweb¨vm Kiv n‡e|
g~mK/Ki gIKz‡di wel‡q Af¨šÍixY m¤ú` wefvM Z_v RvZxq
ivR¯^ †ev‡W©i m‡½ Av‡jvPbvµ‡g †hŠw³K ch©v‡q n«vmmn wewfbœ cÖ‡Yv`bvi D‡`¨vM †bIqv n‡e| G j‡rÉ Jl‡ai
KuvPvgv‡ji Dci M‡elYvq wb‡qvwRZ cÖwZôvbmg~n‡K DrmvwnZ Kiv n‡e Ges cÖ‡qvRbxq cÖ‡Yv`bv †`Iqv n‡e| KuvPvgvj Drcv`‡bi Rb¨ Bmy¨K…Z jvB‡m‡Ýi AvIZvq wdwbm&W WªvM Drcv`b Kiv hv‡e bv|
ïaygvÎ ißvwbi D‡Ï‡k¨ me ¯^xK…Z c×wZi Jla ¯^ ¯^ c×wZi †Kv¤úvbxi mv‡_ Pzw³wfwËK/†jvb jvB‡m‡Ýi AvIZvq (Contract Manufacturing/ Loan License) Drcv`b
Ki‡Z cvi‡e| Drcvw`Z D³ Jla †Kvbfv‡eB ¯ v’ bxq evRv‡i evRviRvZ Kiv hv‡e bv|
D”P cÖhyw³m¤úbœ cixr¡ I ¢h−nÔo−Zl Rb¨ cÖ‡qvRbxq gvïj
cÖ`vb e¨e¯ v’ ax‡b (Contract Analysis) †Kvb cÖwZôvb
Zv‡`i cQ›`g‡Zv Jla cÖkvmb KZ…©K ¯^xK…Z †Kvb mi Kvwi, †emiKvwi I ¯^vqËkvwmZ cÖwZôvb hv‡`i G msµvšÍ cixr¡ I we‡nÔoZ myweav i‡q‡Q Zv‡`i‡K ¯^xK…wZ †`Iqv n‡e| G wel‡q Jla cÖkvmb Awa`ßi cÖ‡qvRbxq MvBWjvBb cÖYqb Ki‡e|
cÖ¯ Z‘ Kvix‡K miKvi †h †Kvb Jla Drcv`‡bi wb‡`©k w`‡Z cvi‡e Ges cÖwZôvb¸‡jv Zv Drcv`‡b eva¨ _vK‡e|
weªwUk dvg©vwmDwUK¨vj †Kv‡W· (BPC)-Gi c~e©eZ©x wZbwU ms¯‹i‡Yi †h‡Kvb GKwU‡Z A_ev wek¦ ¯^v¯’¨ ms¯’vi
B›Uvib¨vkbvj bb-†cÖvcvBUix †bgm& (INN) Gi ZvwjKvfz³ bq †mme Jla Drcv`‡bi AbygwZ †`Iqv n‡e bv|
j‡rÉ wbqwgZ cÖwkrZ cÖ`vb Kiv n‡e| †f‡Uwibvwi WªvM‡mi †r ‡ÎI Dwõ¢Ma wel‡q wb‡qvwRZ Rbe‡ji cr Zv e„w×i
j‡rÉ †f‡Uwibvwi we‡klÁ‡`i Øviv wbqwgZ cÖwkrZ cÖ`vb
Kiv n‡e|
gvbe m¤ú` Dbœqb Kg©m~Px MÖnY Kiv n‡e Ges †mB mv‡_ Kg©iZ Rbe‡ji `r Zv, AwfÁZv I cvidi‡g‡Ýi wfwˇZ
wbqwgZ c‡`vbœwZmn K¨vwiqvi †W‡fjc‡g›U fÔ¨vb (Career
Development Plan) wbwðZ Kiv n‡e|
GKwU wjM¨vj †mj (Legal Cell) MVb Kiv n‡e| bKj
†fRvj I ¢ejÀgv‡bi Jl‡ai Drcv`b, weZiY, gRy` I wewµi wel¦−Ü â¦a AvBbMZ e¨e¯’v †bIqvi j‡rÉ Awa`߇i wePvwiK
ev wbe©vnx g¨v‡R‡÷ªU wb‡qv‡Mi e¨e¯’v MÖnY Kiv n‡e|
e¨e¯ v’ cbvq mykvm‡bi AšÍivq weavq Drcv`K I Avg`vbxKviK cÖwZôvb, cvBKvix I LyPiv we‡µZv G wel‡q `vqe×| Giƒc Jl‡ai Drcv`b, wecYb, weµq, weZiY I
gRy‡`i mv‡_ msn wÔø e¨w³ I cÖwZôv‡bi whl¦‡×
AvBbvbyM K‡Vvi e¨e¯ v’ MÖnYmn Jla cÖkvmb Awa`ßi KZ…©K mswn &Ôø jvB‡mÝ evwZj Kiv n‡e|
A_ev M‡elYv I wK¬wbK¨vj cixr¡j§mL cÖ‡qv‡Mi Rb¨ mywbw`©ó cwigv‡Y I AevwYwR¨K D‡Ï‡k¨ jvB‡mÝ cÖ`vbKvix KZ…r ©c‡l c~e©vbygwZµ‡g Avg`vwb Kiv hv‡e|
j‡rÉ evsjv‡`k dv‡g©mx KvDw݇ji wbewÜZ dvg©vwm‡÷i ZË¡veav‡b mKj dv‡g©mx, miKvwi I †emiKvwi Jla mslre¡N¡l Ges nvmcvZvj dv‡g©mx cwiPvwjZ n‡e|
I weåvwšÍKi Z_¨ cÖ`vb †iv‡a Jla cÖkvmb Awa`ßi KZ…©K Aby‡gvw`Z Ô†KvW Ae dvg©vwmDwUK¨vjm gv‡K©wUs cÖ¨vKU w‡mmÕ AbymiY Kiv n‡e| Jla Drcv`bKvix I wecYbKvix
cÖwZôvmg~n D³ Ô†KvW Ae dvg©vwmDwUK¨vjm gv‡K©wUs cÖ¨vKwU‡mmÕ Abyhvqx Zv‡`i wecYb Kvh©µg cwiPvjbv Ki‡e|
D³ Ô†KvW Ae dvg©vwmDwUK¨vjm gv‡K©wUs cÖ¨vKwU‡mmÕ wbqwgZ nvjbvMv` Kiv n‡e|
†Kvb A‰bwZK wecYb (Unethical Marketing) wKsev eû¯Íi wecYb (Multi Level Marketing) †iva Kiv n‡e|
më, Rb¥ weiwZKiY Jla I wWfvBR, cvwb weï×KiY Jla, Gw›U‡mcwUK Jla, m¤úªmvwiZ UxKv`vb Kg©m~Px‡Z e¨eüZ f¨vKwmb Gi e¯‘wbô, ¢nr¡j§mL Ges Rbm‡PZbZvg~jK
weÁvcb cÖPvi Kiv hv‡e|
M‡elYvwfwËK †`kx, we‡`kx, miKvwi, †emiKvwi I ¯^vqËkvwmZ cÖwZôvbmg~‡ni f~wgKv ¸iæZ¡c~Y©| †`‡k bZzb cÖhyw³ I KvwiMwi Ávb n¯ÍvšÍ‡ii h_vh_ wbðqZvmn be- Avwe®‹…Z Ges D”P cÖhyw³i Jla †hgb-ev‡qv‡UK‡bvjwRcÖm~Z f¨vKwmb, ev‡qvwmwgjvi, ni‡gvb, Bbmywjb, G¨vw›UK¨vÝvi BZ¨vw` Jla Drcv`b I evRviRv‡Zi Rb¨ M‡elYvwfwËK
we‡`kx Jla cÖ¯ Z‘ KviMY‡K DrmvwnZ Kiv n‡e|
EMA, UK-MHRA, Australian-TGA-Gi mb`cÖvß
Jla cÖ¯‘ZKvix cÖwZôvb †`‡k AviI cÖ‡qvRb i‡q‡Q| †mRb¨ M‡elYvwbf©i we‡`kx Jla cÖ¯‘ZKvi‡Ki mv‡_ evsjv‡`‡ki Jla cÖ¯ Z‘ KviK cÖwZôv‡bi †hŠ_ D‡`¨v‡M wkí ¯ v’ c‡b Drmvn cÖ`vb Kiv n‡e|
wbivc` e¨envi, AZ¨vek¨Kxq Jl‡ai aviYv I ZvwjKv,
e¨e¯ v’ cÎwenxb Jl‡ai aviYv I ZvwjKv Ges †KvW Ae dvg©vwmDwUK¨vjm gv‡K©wUs cÖ¨vKwUm welqK cÖ‡qvRbxq †Kvm© Ges †f‡Uwibvwi WªvMm Gi †ÿ‡Î †f‡Uwibvw dvg©v‡KvjwRi †Kvm©-KvwiKzjv‡g welqmg~n AšÍf©y³ Kivi e¨e¯’v †bIqv n‡e|
cÖ¯ Z‘ Kvix cÖwZôvbmg~n Zv‡`i Av‡qi GKwU wbw`©ó cwigvY Ask Jl‡ai Research and Development G RwoZ
e¨w³, miKvwi, †emiKvwi I ¯^vqËkvwmZ cÖwZôvb‡K cÖ`vb Ki‡e|
Reactions Monitoring (ADRM) Cell-†K AviI
kw³kvjx Kiv n‡e| †`‡ki nvmcvZvj I wK¬wbKmg~n, wPwKrmK I dvg©vwm÷e„›`mn Ab¨vb¨ ¯^v¯’¨ †mev cÖ`vbKvixMY, †ivMx, Jla cÖ¯ Z‘ Kvix, evRviRvZKvix cÖwZôvb
I dv‡g©mxmg~n wbqwgZfv‡e ADRM Cell-†K GZwØlqK
Z_¨, DcvË I wi‡cvU© w`‡q mnvqZv cÖ`vb Ki‡e|
cÖwZôv Kiv n‡e|
4.14| Jla Drcv`bKvix cÖwZôv‡bi
`ÿ Rbej
Jla Drcv`bKvix KviLvbvq Avqy‡e©` ¯œvZK B (AMS),
Avqy‡e©` wWf ‡Ô¡j¡ (DAMS), BDbvbx ¯œvZK (BUMS),
BDbvbx wW‡fÔ¡j¡ (DUMS), †nvwgIc¨vw_ ¯œvZK (BHMS),
†nvwgIc¨vw_ wW‡fÔ¡j¡ (DHMS), wWMÖxavix, gvB‡µvev‡qvjwR, dv‡g©mx, †evUvbx, †Kwgw÷ª, ev‡qv‡Kwgw÷ª Ges A¨vfÔ¡CX †Kwgw÷ª wel‡q m¤§vbmn ¯œvZK wWMÖxavix cÖ‡qvRbxq msL¨K gvb-wbqš¿Y Ges Drcv`b Kg©KZ©v wb‡qvM
Ki‡Z n‡e|
4.15| Jla ißvwb
BwáZ Jl‡ai †iwR‡÷ªkb cÖ`vb Kiv hv‡e| Z‡e wek¦ ¯^v¯ ¨’ ms¯’vmn AvšÍR©vwZKfv‡e ¯^xK…Z †Kvb cÖwZôvb KZ©„K †wl NZ v gvbe ev Ab¨ †Kvb cÖvYx‡`‡n A_ev cwi‡e‡ki Rb¨ r wZKi
†Kvb Jl‡ai †iwR‡÷ªkb cÖ`vb ev ißvwbi Aby‡gv`b †`Iqv
n‡e bv|
wecYb Kvh©µg cwiPvjbvi Rb¨ ˆe‡`wkK gy`ªvi wjwgU e„w× I Jl‡ai wecYb Dbœq‡b (Marketing Promotion) ch©vß
bgybv †cÖi‡Yi AbygwZ cÖ`vb Kiv n‡e|
4.16| RvZxq Jla wbqš¿Y ci£r ¡N¡l (National Control Laboratory-NCL)
j‡rÉ RvZxq Jla wbqš¿Y cixr¡N¡l (National Control
Laboratory) †K †idv‡iÝ ÷¨vÛvW© Avg`vwb K‡i IqvwK©s ÷¨vÛvW© ˆZwii `vwqZ¡ †`Iqv hv‡e| Gme ÷¨vÛvW© Zviv Jla †Kv¤úvwbi Kv‡Q cÖ‡qvRb Abyhvqx wewµ Ki‡Z cvi‡e| cvkvcvwk Jla Drcv`bKvix cÖwZôvb‡K †idv‡iÝ ÷¨vÛvW©/IqvwK©s ÷¨vÛvW© Avg`vwbi AbygwZ cÖ`v‡bi eZ©gvb cÖwµqvI Ae¨vnZ _vK‡e|
and Industrial Research BCSIR)-−L m¤ú„³ Kiv
n‡e|
4.17| A¨v‡jvc¨vw_K, Avqy‡e©w`K, BDbvbx I †nvwgIc¨vw_K Jla ‡i Rb¨
Avjv`v Avjv`v AZ¨vek¨Kxq Jl‡ai ZvwjKv cÖYqb
†`‡ki Rb¯^v¯ ¨’ Kvh©Kifv‡e ir¡l ¯^v‡_©, we‡kl K‡i msL¨vMwiô gvby‡li Rl¦¢l cÖ‡qvRb, mnRjf¨Zv I µqrja¡ we‡ePbv K‡i †`‡k cÖPwjZ me wPwKrmv c×wZi (A¨v‡jvc¨vw_K, Avqy‡e©w`K, BDbvbx I †nvwgIc¨vw_K)
Jl‡ai gvS †_‡K evQvB K‡i wKQz msL¨K Jla‡K ÔAZ¨vek¨Kxq Jl‡ai ZvwjKvÕ wn‡m‡e cÖKvk Kiv nj (cwiwkó 1, 2, 3, 4)| wek¦ ¯^v¯’¨ ms¯’vi mycvwikgvjv I ¯^ ¯^
c×wZi ms¢nÔø we‡klÁ‡`i gZvgZ Abyhvqx cÖwZ `yÕeQi
cici GB ZvwjKv nvjbvMv` Kiv n‡e| †f‡Uwibvwi WªvMm Gi
†r ‡Î †f‡Uwibvwi wPwKrmv we‡klÁ‡`i gZvgZ MÖnYc~e©K AZ¨vek¨Kxq †f‡Uwibvwi Jl‡ai ZvwjKv cÖYqbc~e©K cÖKvk Kiv n‡e Ges h_v wbq‡g nvjbvMv` Kiv n‡e| cÖ‡qvRb Abyhvqx AZ¨vek¨Kxq Jl‡ai Drcv`b I mieivn wbwðZ Kiv
n‡e|
RvZxqfv‡e AZ¨vek¨Kxq Jl‡ai ZvwjKv cÖYq‡bi †gŠjbxwZ
MÖn‡Yi j‡rÉ ¯^v¯ ¨’ I cwievi Kj¨vY gš¿Yvj‡qi mwPe Gi
mfvcwZ‡Z¡ wewfbœ †gwW‡Kj K‡j‡Ri Aa¨r , wewfbœ wel‡q
we‡klÁ, wek¦we`¨vj‡qi Aa¨vcK, mswnÔø †ckvRxwe msMV‡bi
cÖwZwbwa, BDbvbx-Avqy‡e©w`K I †nvwgIc¨vw_K †ev‡W©i cÖwZwbwa, gnvcwiPvjK-¯^v¯’¨ Awa`ßi, gnvcwiPvjK-cÖvwY m¤ú` Awa`ßi Ges gnvcwiPvjK-Jla cÖkvmb Awa`ßi
mgš^‡q GKwU KwgwU MVb Kiv n‡e|
4.18| Over-the-counter (OTC) Jla
counter (OTC) Jla wn‡m‡e †kÖwYfz³ K‡i cÖKvk Kiv
nj (cwiwkó 5, 6, 7)| wek¦ ¯^v¯’¨ ms¯’vi mycvwik I mswnÔø we‡klÁ‡`i gZvgZ Abyhvqx Jla cÖkvmb Awa`ßi KZ©„K mgq mgq G ZvwjKv nvjbvMv` Kiv n‡e| †f‡Uwibvwi WªvMm Gi †r−œ †f‡Uwibvwi wPwKrmvq we‡klÁ‡`i gZvg‡Zi wfwˇZ Over the counter (OTC) Jl‡ai ZvwjKv
cÖYqbc~e©K cÖKvk Kiv n‡e Ges h_v wbq‡g nvjbvMv` Kiv n‡e|
4.19| Avqy‡e©w`K, BDbvbx, nve©vj, †nvwgIc¨vw_K I ev‡qv‡Kg wK Jl‡ai gvb Dbœq‡b wRGgwc bxwZgvjv Ges ˆeÁvwbK cÖhyw³-wbf©i gvb-wbqš¿Y e¨e¯’v
†r ‡Î wek¦ ¯^v¯ ¨’ ms¯ v’ i GMP Guideline for Herbal
Medicinal Products AbymiY Kiv n‡e| mvwe©K Ae¯ v’ we‡ePbvq AvMvgx 5 (cuvP) erm‡ii Rb¨ GKwU AšÍe©Zx©Kvjxb wRGgwc bxwZgvjv ˆZwi Kiv n‡e| G wel‡q Jla cÖkvmb Awa`ßi mswnÔø we‡klÁ‡`i mgš^‡q GKwU KwgwU MVb Ki‡e|
n‡e|
Criteria Abyhvqx Jla cixr−Z Drcv`K‡`i wb‡`©k †`Iqv
n‡e|
†Kv‡bv Aby‡gvw`Z ivmvqwbK Dcv`vb (†÷i‡qW, ni‡gvb, †hŠb D‡ËRK A_ev Ab¨ †Kvb ivmvqwbK Dcv`vb) e¨envi
Kiv hv‡e bv| GQvov Gme Jly‡a GdwWwm Kvjvi ev mvwU©dvBW dzW/dvg©v †MÖ‡Wi Kvjvi e¨ZxZ Ab¨ †Kv‡bv Kvjvi ev †d¬fvi e¨envi Kiv hv‡e bv|
Ges Jla kw³Ki‡Yi −r−œ †KejgvÎ †nvwgIc¨vw_K
†idv‡iÝ eBmg~‡ni wb‡`©kbv Abymv‡i cÖ‡qvRbxq B_vBj A¨vj‡Kvnj (†iKwUfv‡qW w¯úwiU) e¨env‡ii Aby‡gv`b †`Iqv n‡e| A¨vn‡Kvnjhy³ †nvwgIc¨vw_K kw³K…Z (c‡UwÝ/WvBjykb) Jl‡ai c¨vK mvBR 30 wg:wj: Gi
†ekx Aby‡gv`b †`Iqv n‡e bv|
4.20 Jlwa¸Y m¤úbœ Dcv`vbhy³ I †ivM wb‡`©kK…Z cY¨‡K Jla wnmv‡e MY¨ Ll¡
4.21| †gwW‡Kj wWfvBm I mvwR©K¨vj BKzBc‡g›U Avg`vwb
¯v’ cb/ms‡hvRb I e¨envi Kiv nq †mme wWfvBm I BKzBc‡g›U Jla cÖkvmb Awa`߇ii wbqš¿Yfz³ _vK‡e|
Rb¨ Drcv`bKvix cÖwZôv‡bi Bmy¨K…Z wRGgwc mvwU©wd‡KU (†Kv‡bv †`‡k wRGgwc mvwU©wd‡KU cÖ`v‡bi cÖ_v bv _vK‡j †m −r−œ Dchy³ KZ©„c‡rl mb`/†iwR‡÷ªkb mb`) `vwLj
Ki‡Z n‡e|
4.22| Jl‡ai wK¬wbK¨vj Uªvqvj (Clinical Trial) I ev‡qvBKzf¨v‡jÝ
cixrZ (Bio-equivalence Study)
Jl‡ai ¸YMZ gvb I Kvh©KvwiZv m¤ú‡K© wbwðZ nIqvi j‡ÿ¨ Jl‡ai ev‡qvBKzf¨v‡jÝ cixr¡ Avek¨K nIqvq G j‡rÉ
AwZâ¦a Globally Accredited ev‡qvBKzf¨v‡jÝ I wK¬wbK¨vj cixr¡ †K›`ª (Bioequivalence Study Centre
and Clinical Trial Centre) ¯ v’ cb Kivi D‡`¨vM †bIqv
n‡e| G −r−œ miKvwi I †emiKvwi D‡`¨vM‡K DrmvwnZ Kiv n‡e| Jl‡ai Bioequivalence Study and Clinical
Trial cwiPvjbvi j‡rÉ Jla cÖkvmb Awa`ßi KZ©„K cÖYxZ MvBWjvBb AbymiY Ki‡Z n‡e| D³ MvBWjvBb mgq mg‡q
nvjbvMv` Kiv n‡e
4.23| WTO/TRIPS Pzw³i Av‡jv‡K evsjv‡`‡ki Jla wkíweKv‡k mnvqZv Kiv
¯^v‡_© G¸‡jvi †gav¯^Z¡ AR©‡b
miKvwifv‡e AbwZwej‡¤^ D‡`¨vM MÖnY Kiv n‡e|
4.24| Lv`¨ I Jla cÖkvmb Awa`߇i iƒcvšÍi I mvsMVwbK KvVv‡gv cybwe©b¨vm
4.25| Jla Drcv`K KZ…©K cwi‡ek `~lY‡iv‡a eR©¨ cwi‡kvab e¨v’ e w ¯bwðZ Kiv
r wZ‡iva Ki‡Z me ¯^xK…Z c×wZi Jla KviLvbvi eR©¨ cwi‡kvab e¨e¯ v’ _vK‡Z n‡e|
4.26| cÖvwYm¤ú` I grm¨ wPwKrmvq e¨eüZ Jla
I †gvoK mvgMÖx‡Z e¨enviwewa mywbw`©ó Ki‡Z n‡e Ges cÖvwYm¤ú‡` e¨eüZ Jla gr‡m¨ e¨envi wbiyrmvwnZ Kiv n‡e|
e¨envi wbiyrmvwnZ Kivi mv‡_ mv‡_ wPwKrmvi Rb¨ Aquaculture Medicinal Product (AMP) Gi
Drcv`b e„w×i Rb¨ Jla Drcv`bKvix cÖwZôvb¸‡jv‡K wb‡`©kbv cÖ`vb Kiv n‡e|
4.27| Rb¯^v‡¯ ¨’ i Rb¨ ¶wZKi Jla evwZj Kiv
5| Dcmsnvi
RvZxq JlabxwZ-2005 ch©v‡jvPbv K‡i JlabxwZ-2016 cÖYqb Kiv n‡q‡Q| G JlabxwZ‡Z Jl‡ai wbivcËv (Safety), Kvh©KvwiZv (Efficacy), †hŠw³K e¨envi, Kvh©Ki Jla wbqš¿Y e¨e¯’v, Jla Drcv`b, wecYb, weZiY, msi¶Y Ges Jla Avg`vwb ißvwbi †¶‡Î my¯úó w`Kwb‡`©kbv i‡q‡Q| G JlabxwZi d‡j Jla wk‡íi AviI weKvk NU‡e,
†`k AwaKZi gvb-m¤úbœ Jla Drcv`‡b mg_© n‡e Ges Jla ißvwbi
m¤¢vebv A‡bK¸Y e„w× cv‡e” |
−j ¡q¡Çjc S¢ql¦m Cpm¡j he¡j h¡wm¡−cn plL¡l J AeÉ¡eÉ (l£V ¢f ¢Vne ew 5508/2017) ®j ¡LŸj¡u A¢i ja fÐc¡e Ll¡ qu ®k,
Strict Liability and Doctrine of Res Ipsa Loquitor:
mvsweavwbK AvB‡b ¶wZc~i‡Yi bxwZ m¤c‡K© Strict Liability and Doctrine of Res Ipsa Loquitor bxwZi Dci ¸i“Z¡ Av‡ivc Kivi cÖ‡qvRbxqZv i‡q‡Q| Pushpabhai Purshottam Udeshi & Others v. M/s. Ranjit Ginning & Pressing Co. (P) Ltd. & Anr., (1977) 2 SCC 745 bvgK fviZxq mycÖxg †Kv‡U©i iv‡q fviZxq mycÖxg †KvU© wbæfv‡e bxwZwU e¨vL¨v K‡i:
"6. The normal rule is that it is for the plaintiff to prove negligence but as in some cases considerable hardship is caused to the plaintiff as the true cause of the accident is not known to him but is solely within the knowledge of the defendant who caused it, the plaintiff can prove the accident but cannot prove how it happened to establish negligence on the part of the defendant. This hardship is sought to be avoided by applying the principle of res ipsa loquitur. The general purport of the words res ipsa loquitur is that the accident "speaks for itself" or tells its own story. There are cases in which the accident speaks for itself so that it is sufficient for the plaintiff to prove the accident and nothing more. It will then be for the defendant to establish that the accident happened due to some other cause than his own negligence. Salmond on the Law of Torts (15th Ed.) at p. 306 states: "The maxim res ipsa loquitur applies whenever it is so improbable that such an accident would have happened without the negligence of the defendant that a reasonable jury could find without further evidence that it was so caused". In Halsbury's Laws of England, 3rd Ed., Vol. 28, at page 77, the position is stated thus: "An exception to the general rule that the burden of proof of the alleged negligence is in the first instance on the plaintiff occurs wherever the facts already established are such that the proper and natural inference arising from them is that the injury complained of was caused by the defendant's negligence, or where the event charged as negligence 'tells its own story' of negligence on the part of the defendant, the story so told being clear and unambiguous". Where the maxim is applied the burden is on the defendant to show either that in fact he was not negligent or that the accident might more probably have happened in a manner which did not connote negligence on his part ...........”
fvi‡Zi mycÖxg‡KvU© weL¨vZ D. D. Basu v Union of India (1997) 1 SCC 416 wbæiƒc AwfgZ e¨³ K‡ibt
"A court of law cannot close its consciousness and aliveness to stark realities. Mere punishment of the offender cannot give much solace to the family of the victim-civil action for damages is a long-drawn and a cumbersome judicial process. Monetary compensation for redressal by the court is therefore, useful and at times perhaps the only effective remedy to apply balm to the wounds of the family members of the deceased victim, of may have been the bread winner of the family."
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UU© Z_v ¶wZc~iY AvB‡b wfKvwiqvm jvqvwewjwU (Vicarious Liability) bxwZwU mvsweavwbK AvB‡b †gŠwjK AwaKvi i w−Nl †¶‡ÎI mgfv‡e cÖ‡hvR¨| mvsweavwbK AvB‡b ¶wZc~i‡Yi bxwZwU eZ©gv‡b mycÖwZwôZ| mvsweavwbK AvB‡b miKvi ev miKvix KZ©…c¶ Zv‡`i Aaxb¯’ Kg©KZ©v ev Kg©Pvix‡`i `vwq‡Z¡ MvwdjwZi Rb¨ ¶wZc~iY w`‡Z eva¨| Z‡e miKvi GB mgcwigvY UvKv `vwq‡Z¡ MvwdjwZi Rb¨ `vqx pw¢nÔø Kg©KZ©v, Kg©Pvix Ges wVKv`vi‡`i KvQ †_‡K AvBbMZ c×wZ‡Z Av`vq K‡i miKvix †KvlvMv‡i Rgv w`‡eb| GB bxwZwUi d‡j miKvix †KvlvMvi †_‡K ¶wZc~iY w`‡jI `vwq‡Z¡ Ae‡njv †h me Kg©KZ©v ev Kg©Pvix K‡i‡Q Zv‡`i KvQ †_‡K GB UvKv Av`vq K‡i miKvix †KvlvMv‡i Rgv ®cu¡ q−hz
h¡wm¡−c−n p¡w¢hd¡¢eL BC−e r ¢af§l−Zl e£¢a¢V fÐbj NËqZ Ll¡ qu 29.05.2012 a¡¢l−M j ¡ee£u Bf £m ¢hi ¡N LaѪL h¡wm¡−cn he¡j e¤l¦m B¢je Hhw AeÉ¡eÉ (3 CLR (AD) (2015) 410) ®j ¡LŸj ¡uz Eš² ®j¡LŸj¡u avL¡m£e j ¡ee£u f Ðd¡e ¢hQ¡l¢a ®j ¡x ®j¡S¡−Çjm ®q¡−pCe h−me ®k,
“46. In awarding and determination of compensation of High Court Division, in an appropriate case if it deems necessary, may take evidence to clear any disputed question of facts or pass any direction or orders to hold an inquiry by a District Judge for removing any controversy as was done in the case reported in (1993) 2 SCC 746. Having considered the development of the law regarding compensatory jurisprudence with reference to the experience in India, Ireland, Privy Council and the Court of Appeal in New-Zealand, we have no hesitation in holding that the paramount object and purpose for which Article 102 has been enacted and the relevant factor and provision on which the interpretation of the Article 102 has been linked, the High Court Division in exercise of its jurisdiction under Articel 102 of the Constitution, which is an instrumentality and a mechanism, containing both substantive and procedural provisions “to realise the objectives, purposes, polices, rights and duties which [the people] have set out for themselves and which they have strewn over the fabric of the Constitution,” can award monetary compensation or compensatory cost mostly in appropriate cases for violation of fundamental rights which must be gross and patent i.e. incontrovertible and ex-facie glaring or that violation should appear unjust, unduly harsh or oppressive on account of the victims disability or personal circumstance.”
Aaxfl ®SX. BC. M¡e f¡æ¡ he¡j l¡øÌ (4 CLR (2016) 265) ®j ¡LŸj ¡u Aœ ¢hi ¡N LaѪL p¡w¢hd¡¢eL BC−e r ¢af §l−Zl e£¢a¢V NËqZ L−l ¢hNa Cw−lS£ 13.09.2015 a¡¢l−M ¢pÜ¡¿¹ f Ðc¡e Ll¡ qu ®k,
“70. The Courts have the obligation to satisfy the social aspirations of the citizens because the courts and the law are for the people and expected to respond to their aspirations. A court of law can not give blind eye of stark realities. Mere punishment of the offender can not give much solace to the family of the victim. A civil action for damages is a long drawn out and cumbersome judicial process. So monetary compensation by way of redress is, therefore, useful and at times perhaps the only effective remedy to apply balm to the wounds.
Aaxf l ¢p¢p¢h g¡E−äne he¡j plL¡l (5 CLR (2017) 278) ®j ¡LŸj ¡u Aœ ¢hi ¡N LaѪL p¡w¢hd¡¢eL BC−e r ¢af §l−Zl e£¢a¢V NËqZ L−l ¢hNa Cw−lS£ 18.02.2016 a¡¢l−M A¢i ja fÐc¡e Ll¡ qu ®k,
“46. The issues being raised in the instant writ petition by the petitioner involves grave public injury as well as invasion on the fundamental right to life of the victim guaranteed under the Constitution. Accordingly, it has sought protection of this Court, the guardian and custodian of the Constitution of the People’s Republic of Bangladesh, for violation of the said right by filing application under Article 102 of the Constitution for the bereaved poor family members of the 4 years old boy named Jihad who died by falling into an uncovered deep tube well pipe of Bangladesh Railway situated at Shahjahanpur Railway Colony. As such, it cannot be said that the petitioner has no locus standi on the issue in question. In other words, this Rule is maintainable so far the locus standi of the petitioner Foundation is concerned.”
Eš² ®j ¡LŸj ¡u B−l¡ A¢i j a f Ðc¡e Ll¡ qu ®k,
“98. Accordingly, this Court finds that the instant writ petition under Article 102 of the Constitution of the People’s Republic of Bangladesh is maintainable, for, the said negligence of the respondent Nos.3, 5 and 4 has culminated in infringement of the fundamental right to life of the deceased Jihad guaranteed under Article 32 of the Constitution.”
¢p¢p¢h g¡E−äne he¡j plL¡l ®j¡LŸj¡u f Ðcš Ef ¢l¢õ¢Ma l¡−ul ¢hl¦−Ü plL¡l CIVIL PETITION FOR LEAVE TO APPEAL NO. 3929 OF 2017 WITH C. P. NO. 3987 OF 2017 c¡¢Mm Ll−m j ¡ee£u Bf £m ¢hi ¡N m£i f Ðc¡e e¡ L−l pl¡p¢l M¡¢lS L−l ®ce (6 CLR (AD) (2018) 282)z
Aaxf l LÉ¡V¢le¡ j¡p¤c he¡j L¡−pc ¢ju¡ (70 DLR (2018) 349) ®j ¡LŸj ¡u Aœ ¢hi ¡N LaѪL p¡w¢hd¡¢eL BC−e r ¢af §l−Zl e£¢a¢V NËqZ L−l ¢hNa Cw−lS£ 03.12.2017 a¡¢l−M A¢i ja fÐc¡e Ll¡ qu ®k,
“197. So, the principle followed in Bangladesh Beverage case and the criteria applied was the potential income of the decessed victim, as salaried person upto his retirement. Following Similar criteria in this case, we hold that the quantum of compensation claimed by claimant No. 1 Catherine and claimant No. 2 Nishadd Binghamputra Masud on account of loss of their dependancy is reasonable, in that Tareque had a monthly income of Taka 2,50,000 and the claim is for 100 (one hundred months) i.e. total amount of Taka 2,50,00,000.”
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