Mumbai : The Drugs Technical Advisory Board (DTAB) of the Union health ministry has turned down a proposal by the ministry to amend Rule 65 of the Drugs & Cosmetics Rules, 1945 to provide that the chemist may offer for supply a drug formulation containing the same ingredients but in generic or other cheaper brand name.
According to sources, the DTAB which held its 71st meeting on May 13, 2016 did not find favour with the health ministry’s proposal in this regard as the experts in the Board, after detailed discussion, felt that there is no guarantee that the bioavailability of the generic medicine so offered by the chemist will be the same as prescribed by the physician and the lack of same effectiveness of the generic medicine may lead to harmful effect on the patient.
Under sub-rule 11A of Rule 65 of the Drugs and Cosmetics Rules, 1945 it is provided that the chemist shall not supply any other preparation whether containing the same substance or not in lieu thereof to the prescribed drug. The sub-rule reads as under: “11 A. No person dispensing a prescription containing substances specified in Schedule H and Schedule H1 or X may supply any other preparation, whether containing the same substances or not in lieu thereof.” But in the DTAB meeting held on May 13, the health ministry proposed to amend the clause to authorise the chemist to sell the matching salt of the branded medicines prescribed by the doctor to the patient especially at Jan Aushadhi stores which will be making available generic medicines at affordable prices.
The proposal read as, “11 A. Person dispensing a prescription containing substances specified in Schedule H and Schedule H 1 or X may offer for supply another preparation, containing the same substances in generic or other brand name.” The intention of the Union health ministry by introducing this proposal to amend Rule 65 of the Drugs and Cosmetics Rules, 1945 was to provide medicines to the common people at cheaper rates, especially through Jan Aushadhi stores.
Earlier, the department of pharmaceuticals had launched a country wide campaign for opening of Jan Aushadhi stores in the country under the Pradhan Mantri Jan Aushadhi Yojana. The drugs covered in this scheme would be generic drugs that would be available at lesser prices than the market price and this way people could have access to the expensive drugs at discounted prices. However, after detailed deliberations, the DTAB did not agree to the proposed amendment.