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DTAB turns down govt proposal to empower chemists to supply alternative cheaper drugs with same ingredients

Ramesh Shankar, Mumbai
Tuesday, June 7, 2016, 08:00 Hrs  [IST]

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 and 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.


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SATYANARAYAN GARG Jun 12, 2016 10:56 PM
At present the consumer is at the mercy of doctors to prescribe costly medicines ,and the proposal if ever implemented will put the consumer at the mercy of pharmacist. It is very strange that consumer who is paying is hard earned money is not having any say in choice of medicines . It is very doubtful that doctors are having any track record of their prescriptions ,which is needed to ascertain the effectiveness of a particular brand fir the same drug/formulation. In my opinion consumer shall be empowered to take the decision regarding purchase of prescribed brand or its equivalent substitute.
Rajesh verma Jun 8, 2016 4:47 PM
it is well known doctor prescribe low quality drug with high MRP by taking cammision or gift or tour package what is say DTAB about it .
i think pasent have freedom for choose brand
Prabhakumar B G Jun 7, 2016 7:06 PM
If bioavailability and efficacy are doubted, how come that are allowed to be in the market ?. The DTAB decision is strange.
J P THAKUR Jun 7, 2016 12:46 PM
DTAB must do his best to implement PPR-2016 from urban to rural part of india before objecting the proposal of Union health ministry OR bioavailability of generic/branded should not differ.

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