Law on generic drugs to face stiff resistance

The government will have to overcome multiple legal and commercial challenges before it can introduce a law to make it mandatory for doctors to prescribe low cost generic drugs, say experts.

Such a legislation is sure to be challenged in the court by pharmaceutical companies, which would raise critical questions for being singled out in the market as most of the commercial products in India are sold under a brand name.

Prime Minister Narendra Modi’s comments hinting at a new law for doctors have stirred a hornet’s nest in the healthcare sector.

“Doctors write prescriptions in such a way that a poor person does not understand the handwriting, and he has to buy that medicine from private stores at high prices. We will bring in a legal framework by which a doctor, in his prescription, has to mention that it is enough for a patient to buy generic medicine and that he need not go for any other medicine,” Modi had said in Surat on Monday.

Industry watchers felt such a law will have to keep the fixed dose combinations (FDC), patented medicines, medical devices, and several drugs for epilepsy and asthma outside its purview. The FDCs, for instance, constitute up to 52% of the Indian medicine market and values around Rs 50,000 crore.

Widespread use of generic medicines, according to the experts, is possible only when all generic medicines are of the same quality. But studies carried out by eye specialists at AIIMS, Delhi, in April 2017 demonstrate sharp variations in the quality of a generic drug used in glaucoma, a severe eye condition.

“It’s impossible to transfer the legal authority of a doctor to a chemist or pharmacist, who does not even have to see the patient before handing over the medicine. Who would be responsible if a doctor prescribes a particular brand of generic medicine and the pharmacist gives a poor quality generic medicine, leading to clinical complications?” C M Gulhati, a former consultant to the WHO, said.

He said strict implementation of cost-based price control was the only way to break the nexus between doctors and pharmaceutical companies.