Close on the heels of Prime Minister Narendra Modi's announcement that the government may come up with a legal framework mandating doctors to prescribe generic drugs, Maharashtra Registered Pharmacists Association (MRPA) has urged Central Drugs and Standard Control Oragnisation (CDSCO) to reconsider health ministry's proposal to empower pharmacists to dispense generics or other cheaper brands containing the same ingredients of branded drugs prescribed by doctors.

At a function in Surat recently, PM said "We will introduce a legal framework by which if a doctor writes a prescription, he has to write in it that it will be enough for patients to buy generic medicine and he needs not buy any other medicine.”

Last year the health ministry proposed to amend Rule 65 of the Drugs and Cosmetics Rules, 1945 to authorise the chemist to sell matching salt of the branded drugs prescribed by the doctor to the patient specially at Jan Aushadhi stores which will be making available generics at affordable prices. The Drugs Technical Advisory Board (DTAB) rejected the ministry's proposal at its 71st meeting held on May 13, 2016 saying that there is no guarantee that bioavailability of the generics so offered by the chemist will be same as prescribed by the physician and the lack of same effectiveness of the generics 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. Sub -rule 11A reads “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.”

MRPA president Kailas Tandale in a letter to CDSCO on April 22, 2017 appealed to reconsider the health ministry's proposal to ensure that people get quality drugs at cheaper rates both at Jan Aushadhi stores and chemist shops.

He said that as per the law, generics are launched in the market after meeting stringent bioavailability and bioequivalence and proper quality control and quality assurance criteria. Its responsibility of state drug controllers and Drug Controller General of India (DCGI) who provide licenses for production and sale of various drugs in states to ensure quality, safety and efficacy of all drugs sold in the country, he said.

MRPA had in June last year written to CDSCO opposing DTAB decision to turn down health ministry's proposal.

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 to provide quality drugs at lower prices. The drugs covered in this scheme and drugs of other pharmaceutical companies i.e. branded generics would be available at Jan Aushadhi stores at lower prices.