While Prime Minister Narendra Modi has said that “legal arrangements” will be made to make prescription of generic medicines compulsory, the fact is that this is already mandatory . The Medical Council of India’s ethics code for doctors made generic prescription mandatory in October 2016, though it has never been enforced.
Health being a state subject, the other method the Centre has of regulating prescription practices is by reining in pharmaceutical companies from bribing doctors to prescribe their drugs. However, the Uniform Code of Pharmaceutical Marketing Practices (UCPMP), which was to prevent such unethical practices, has been hanging fire for two years.
The MCI’s regulatory code for doctors made generic prescription mandatory in October 2016 through a change in the code notified in the gazette. “The doctors’ code of conduct is only a code governed by the MCI that is not being followed. The council acts only if complaints are filed and the only penalty is suspension or cancellation of licence, which rarely happens, and it can be challenged in a court.There has to be a stronger legal arrangement with penal provisions and consequences for violation to ensure that it is followed,” said Malini Aisola of the All India Drug Action Network. Aisola added that UCPMP was to be made statutory , but is long overdue.
The UCPMP announced in January 2015 was to be made mandatory after a six month trial period as a voluntary code. Instead, four extensions were given, with the last one in September last year for an indefinite period.
“The draft of the UCPMP is ready and waiting to be notified by the department of pharmaceuticals. The government is stalling because of pressure from the pharma lobby . This is not the first time that the government has succumbed to pressure from the pharmaceutical industry ,” said Amitava Guha of Jan Swasthya Abhiyan, a healthcare rights group.
The Union health ministry had recently tweaked a section on labelling in the Drugs and Cosmetics Rules that called for generic names to be displayed more conspicuously on the packing. The draft notification of these changes proposes to make it mandatory for pharma companies to carry generic names of a medicine in a font at least two sizes larger than the brand name.
“This latest proposal has to be strengthened for it to be effective. The generic names are already being written in double the font size, but in a manner that makes it difficult to read. Brand names are prominently displayed against a contrast background. The new notification does not address this,” said Aisola.
She pointed out that while off-patent drugs account for over 95% of the market in India, the marketing formula is very much brand-based. This is due to the largely Indian phenomenon of “branded generics” – a term used to describe drugs that have gone off patent but are sold under brand names rather than the chemical name of the drug by companies other than the original patent holder.
Courtesy: Rema Nagarajan, The Times of India