Suggestion: G.S.R No. 223 (E) 18-03-2019, Form 39(A)

Last Updated on June 29, 2021 by The Health Master

Immediate benefits

In the recent amendment in Drugs and Cosmetics Act Rules (DCR) vide GSR no. 223(E) dt. 18th March 2019, Govt. of India has introduced a new form no. Form 39(A) for issuance of report of test or analysis by approved institution for an Individual or Organisation or Procurement agency by amending Rule 150B, 150C, 150E and Schedule A.

By bringing such amendment in DCR the following immediate benefit will be resulted towards asserting quality of drug / cosmetic / raw material before their consumption:-

• Individuals or Organisation or Procurement agency will be able to test their drug sample in approved Laboratory / Institution to ascertain the quality of drug before distribution / consumption by the needy patient.

• An individual can also ascertain the quality of a drug / cosmetic so purchased / procured by sending the sample to approved Institution.

• An individual organisation can also test raw materials used in the manufacture of drugs including homeopathic drug or cosmetic in an approved institution (As per the Explanation-under Rule 150B)

Suggestion

Keeping in view of the above immediate statutory benefits towards asserting the quality of drug or cosmetic or raw materials used in the manufacture of drugs including homeopathic drug or cosmetic.

Also read: Analysis: ‘Provisions for Manufacturing of Drugs for Examination, Test or Analysis’

Introduction of a new Form

It may be necessary to bring about further amendment in DCR to make provision towards procedure for dispatch of sample to approved institution and also to make provision for introduction of a new Form for sender’s memorandum (As mentioned in Serial no. 2 of the Form 39A) to adopt an uniform procedure for avoiding duplication of sample and defacing of original packing and label of the drug / cosmetic / raw material.

In part XV(A) of DCR– introduction of new Rule 150L:-

Procedure for dispatch of sample to approved institution –

(1) The sample or the container sent by an individual or organisation or procurement agency shall be sent by Registered post or by hand in a sealed packet enclosed together with a memorandum in Form 38A, in an outer cover address to the approved institution.

(2) A copy of the memorandum and a specimen impression of the seal used to seal the packet shall be sent to the approved institution separately by registered post or by hand.

Also read: Analysis: GSR 828(E) dt. 06.11.2019 on Submission of Undertaking on Brand Names of drugs

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FORM 38A

(See rule 150L)
MEMORANDUM TO APPROVED INSTITUTIONS

Serial No. of Memorandum…………………………………..

1.Full Name and Address of the Sender………………………..

2.Occupation / Designation……………………………..

• Name of Drug or Cosmetic or Raw material purporting to be contained in the sample………………………….
• Details of Raw material or Drug or Cosmetic:-
  • Name and Address of the Manufacturer and License No, mentioned on the Label………………………………….
  • Name of original manufacturer in case of raw materials and repacked drugs…………………………………

(c) Batch No. ………………………………………

(d) Date of Manufacture/Repacking Date, If any…………………………………

(e) Date of Expiry, If any…………………………………….

• Name and Full address of the pharmacy / firm or company from whom the drug or cosmetic or raw material was purchased / procured………………….

6.Date on which purchased………………………………

7.Reasons why the Drug / Cosmetic / Raw material is being submitted for test or analysis…………………………….

I hereby declare that the sample of the drug / cosmetic / raw material being sent for test or analysis is exactly as it was purchased and has not been tampered with in any way to reduce its potency.

Date………………………

Signed………………………………

(Seal/Stamp or Organisation/Procurement Agency)

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Disclaimer: This is the personal opinion of the author and anyone may have a different opinion.

Also read: Suggestions for conducting a decoy operation on Medical Shops

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