Image result for generic drug

Subsequent to PM Narendra Modi’s announcement that doctors need to prescribe generic drugs, Indian Medical Association (IMA) has reiterated its support on the same provided the government ensures availability of generic medicines through Jan Aushadhi stores and ensures quality through proper regulatory controls. It has also recommended to bring branded generics under price control to make expensive generics affordable.

IMA has also clarified that Medical Council of India (MCI) has also framed prescription guidelines two years ago which clearly spells out prescribing generic medicines as per the code of medical ethics stipulated as per the MCI Act.

The mandatory code for doctors to ensure generics get precedence over branded drugs is possible only if the government can bring branded generics under price control, says an official.

PM has also announced that the government is working to bring in a legal framework under which doctors will have to prescribe low cost generic medicines to patients.  The PM’s statement raised concerns among many about how this could be done without tapping other parts of the supply chain including pharmacists and distributors, who often push drugs with higher margins.

However, senior officials in the government suggested the PM’s statement was supported by a multi-pronged strategy already in the works under different ministries and departments and changes to relevant laws.

Apart from DoP, the health ministry, Drugs Controller General of India, the National Pharmaceutical Pricing Authority (NPPA) and the Medical Council of India have been tasked to strengthen different laws and regulations to ensure consumers can be empowered to make informed choices.

The NPPA is also trying to cap trade margins for not only branded generics but also generic drugs. The latter are drugs being sold only as the chemical formulation that is not currently capped.

Similarly, the health ministry has asked MCI to enforce the order it issued in October and make it mandatory for doctors under the law to write the generic name of drugs in legible handwriting. It is also trying to ensure consumers can distinguish between generic names and branded names by asking companies to conspicuously mention the generic name on packs. While earlier most of the attempts were in the form of advisories and guidelines, with new provisions any violation will be punishable with hefty penalties and even amount to cancellation of licenses for doctors, manufacturers, and pharmacists.

Apart from the supply chain, the DCGI has also issued orders to state drug regulators to grant manufacturing licenses to companies only based on generic names of their products, instead of brands. This is being seen by many as an attempt to promote generic drugs.