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Nandita Vijay, Bengaluru October 28 , 2017
From Union government initiatives, Medical Council of India (MCI) norms to patent expiry and affordability are all expected to spur the prescriptions of generic drugs in the country, said Prof S Mohan, director, PES College of Pharmacy.

In India, poor accessibility and affordability of people compel use of generic drugs to minimize cost of treatment. However there is a scepticism on the quality and the safety issues when it comes to branded versus generic medicines, he added.

Moreover since the generics are priced considerably lower, the revenue earned in the supply chain is lower. So branded drug companies in India could prevent government’s move to promote generics, said Prof Mohan who was addressing at the recently concluded Assocham meet on ‘Ensuring Quality Standards in Generic Drugs’.

He went on to state that there was no reason to doubt on the quality of generic drugs if it is manufactured using the right strength of the active pharmaceutical ingredients which indicate the desired pharmacological action.

Generic drugs are currently the highest earners within India’s pharmaceutical industry, accounting for 70% of market share by revenues. India is the largest provider of generic drugs and exports to over 200 countries. India accounts for 20 per cent of global generic drug exports in terms of volume. Globally this market is growing at a compounded annual growth rate of 10.53% from 2016 and is expected to sustain this momentum through 2020.

Department of Pharmaceuticals launched the ‘Jan Aushadhi Campaign’, to provide quality generic medicines at lower prices. In the 2016-2017 Union budget, the government announced its intent of opening of 3000 ‘Jan Aushadhi stores'. MCI in September 2016 notified an amendment in Clause 1.5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002. Under the revised clause every physician needs to prescribe drugs with generic names legibly penned down, preferably in capital letters based on a prescription.

In October 12, 2012 Government of India issued directions that the drugs will be sold under their generic name rather than their brand names. This directive created confusion regarding choice of branded generics because almost 90% drugs in India are known by their branded generic names, he said.

In developed countries such as the US, only patented drugs are sold under a brand,. Off-patent drugs are sold only as pure generic, without using any brand name. It helps in making pure generics cheaper. But in India, most of the generic drugs are sold in its brand name and referred to as brand generics, said Prof Mohan.

Therefore the government must take up generic promotional schemes, general awareness programs on quality of generics to build confidence among prescribers, pharmacists and consumers. Availability of generics or branded-generics in the market with lower price tag and assured quality is essential to make the medicines affordable, said Prof Mohan.

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