The government will seek to make legal arrangements to prevent doctors exclusively prescribing expensive, brand name medications said Prime Minister Narendra Modi, speaking at the inauguration of a hospital in Surat on April 17.
The new law would govern the way in which prescriptions are written. Currently a doctor may prescribe a brand name medication; if this law comes to pass, it would force the doctor to write the specific medication name. This would allow the chemist to offer the patient a cheaper generic version of the product where it is available. ,
This law presents the opportunity to massively help the poor who cannot afford the price of expensive brand names. However, it depends on chemists actually offering cheaper generics or on a massive increase in patient awareness.
Prime Minister Modi thinks this move is likely to anger many of the large pharmaceutical companies. During the inauguration of the hospital he discusses this possibility:
“you can imagine how angry the manufacturers of medicines will be. Despite the wrath of a very powerful lobby, the government is taking one step after another so that poor people and middle class get quality health services”
This would further increase tensions with large pharmaceutical companies as it follows laws forcing manufacturers to place the maximum price on packaging of medical devices, as well as capping yearly price increases on many pharmaceutical products. The highly publicised issue of cardiac stents was also concluded with a government issued price cap.
However, the products most likely to be hard hit are branded generics. New, innovative medicines are protected by patents and do not have generic equivalents. Once the patent has expired, generic companies often launch their own high-priced brands which they promote aggressively to doctors.
This year has seen a number of laws passed that have placed the government at odds with pharmaceutical companies. This may cause issues with the public-private partnerships Modi wishes to take advantage of to part-fund improvements to the healthcare sector.
States such as Delhi already have schemes that make the use of cheaper generic medications mandatory. They have drawn mixed results: some argue that where 10 percent of India’s patented drugs are out of reach of the poor the moral thing to do is to issue the cheaper alternatives. But, the cheaper alternatives have drawn concerns over their quality.
Many generic drugs that have been approved in India have been suspended from sale in other parts of the world. A recent example of this is the case of 300 generic drugs being suspended by the European Medicines Agency, and banned from distribution in the EU. The drugs had been tested by Chennai-based company Micro Therapeutic Research Labs, a contract research organisation conducting analytical and bioequivalence studies.
The reason for the drugs being banned was stated as concerns related to the study data and deficiencies in documentation during the trial period of the drugs. This places the safety and efficacy of the generics on sale in India under question, as they do not pass international standards.
The Times of India reports, without a source, that 70 to 75 percent of a household’s out of pocket healthcare expenditure is on medications. If that is so, this move may massively affect the ability of the poor to access medicines.