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Health ministry warns on rushed implementation of generics plan

LiveMint logoLiveMint 07-08-2017 Teena Thacker

New Delhi: The ministry of health and family welfare has recommended that the prime minister’s idea of mandating doctors to prescribe medicines by chemical names and not brands be implemented carefully, and over time, to ensure that the right quality and quantity of drugs are available.

The ministry said “it will not be possible” to do this “in the next two-three years even if it is made mandatory”. “On the other hand, it will cause scarcity of quality medicines”, it said in a July presentation to the prime minister’s office. Mint has reviewed a copy of the presentation.

In April, Prime Minister Narendra Modi said that the government was considering enacting a law making it mandatory for doctors to prescribe generics. He meant getting doctors to prescribe drugs by their chemical names in an effort to break the Doctor-Big Pharma nexus that often increases the cost of healthcare. Many doctors prescribe generics (off-patent drugs) but branded ones.

Following this, the health ministry and the Medical Council of India, both of which support the move (the latter, in fact, had issued a directive to doctors last year to this effect) started studying the matter.

In its presentation, the health ministry expressed concerns over the efficacy, safety and effectiveness of some generic drugs because they do not undergo bioavailability and bioequivalence (or BABE) studies. These measure the rate and extent of absorption of drugs in the human body. “Many generics currently available in the Indian market have not undergone BABE studies. The government has recently made BABE mandatory. This will take some time and that’s what has been shared by the ministry,” said R.K. Vats, additional secretary in the health ministry, explaining the ministry’s position.

“The common man and the country will benefit if both quality and prices are emphasized.”

The ministry also highlighted other issues in rushing through this change, with the doctor-Big Pharma nexus at risk of becoming a Big Pharma-chemist nexus and problems for both doctors and patients with “complicated” names of some drugs.

For doctors to prescribe drugs by their chemical names, more needs to be done, said Anoop Misra, chairman, Fortis C-Doc, a multi-speciality hospital in Delhi. “This will involve strict quality control, and proper distribution by retail outlets to reach under-served areas. All this is possible but will take time, preparation, planning and political will.”

Misra’s comment on quality needs to be seen in the context of a recent study by the health ministry which found that almost 3.16% of the drugs in India are “not of standard quality”, with the proportion rising to 10% in government supplies.

“They can make a beginning. But it’s going to take some time to move completely”, to prescribing drugs by their chemical names, said Daara B. Patel, secretary general, Indian Drugs Manufacturers’ Association.

Although the ministry supports the Prime Minister’s idea, its suggestion that the implementation be done over time “undermines public health”, said Leena Menghaney, South Asia head of the Access Campaign by Médecins Sans Frontières (doctors without borders). “Quality assurance is not linked to brands that doctors think are good but to the adherence by pharma firms to WHO GMP (good manufacturing practices) and stricter inspections and licensing by the drug regulatory authorities in India,” she added.

The ministry does have a suggestion for accelerating the process. In its presentation, it said the government could only procure unbranded generic drugs or, under the Pradhan Mantri Bhartiya Janaushadhi Pariyojana, which aims to provide cheaper medical drugs to people, get “private manufacturers to supply medicines in generic names”.

“This way, in about two years’ time, a good share of the market can be captured by generic generics,” it added.

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