Wednesday, December 26, 2012
The government of India is all set to crack the whip on India's shameful pharma-doctor nexus. The National Development Council (NDC), led by Prime Minister Manmohan Singh, will meet on December 27 to discuss bringing a legislation requiring to mandatorily disclose payments made to doctors for research, consulting, lectures, travel and entertainment. Doctors involved in ghost writing to promote pharma products will also be disqualified.
The official NDC document says, "Mandated disclosure by of the expenditure incurred on , and penalty on the company and vetting of drug related material in continuing would be considered."
The Planning Commission says pharmaceutical marketing and aggressive promotion contributes to of drugs and therefore there is a need for a mandatory code to identify and penalize unethical promotion by . The government will also make compulsory the use of generic names or the International Non-proprietary Name (INN), instead of brand names, at all stages of government procurement, distribution, prescription and use.
"Brand manufacturers will be encouraged to bid for government procurement, but should provide medicines in generic names," the document says.
Health minister Ghulam Nabi Azad recently said the ministry had received several complaints on this unholy pharma-doctor nexus.
According to the Medical Council of India (MCI), it received 702 such complaints in 2011-12 of which 343 were referred to state medical councils. In 2010-11, MCI received 824 such complaints following which it cancelled the registration of 10 doctors and warned four others.
Drug companies were recently caught red-handed writing scientific recommendations of their own products and submitting them to the Drug Controller General of India (DCGI) after getting them endorsed by top doctors for quicker marketing approval.
Usually, scientific recommendations are submitted by experts after they have studied a drug's content. The endorsement is considered a crucial testimony that convinces the DCGI to trust the drug's effectiveness, in turn, allowing it to be launched in the market.
Some of India's top medical experts — even heads of departments — from the country's most prestigious medical institutes such as PGI Chandigarh, CMC Vellore, AIIMS Delhi and St John's Medical College, Bangalore had signed recommendations for drug companies which may have been written by the companies themselves.
A recent study by the Planning Commission's high-level expert group (HLEG) said the pharmaceutical industry spent more than 25% of its annual turnover on sales promotion alone as compared to a paltry 7% on research and development in 2008-09.
India plans to soon introduce the 'Uniform Code of Pharmaceutical Marketing Practices' after which the word "safe" cannot be used on a drug without qualification and it must be stated categorically that a medicine has no side-effects, toxic hazards or risk of addiction.
The code says, "No gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to persons qualified to prescribe or supply by a pharmaceutical company. Gifts for the personal benefit of healthcare professionals (such as tickets to entertainment events) also are not be offered or provided. Companies must not organize meetings to coincide with sporting, entertainment or other leisure events. Venues that are renowned for their entertainment must not be used."
It adds, "Any hospitality offered to healthcare professionals must not be extended to spouses. Funding of healthcare professionals to compensate them for the time spent in attending the event is not permitted."
Planning Commission member Syeda Hameed recently took the example of the Food and Drugs Administration (FDA) of the US and how it has mandated strict regulations to curb unethical promotions.
These include mandated disclosure by pharmaceutical companies of the expenditure incurred on drug promotion, ghost writing in promotion of pharma products to attract disqualification of the author and penalty on the company and vetting by FDA of drug related material in CME.