Government of India to crack whip on India`s pharma-doctor nexus
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 drug companies
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 pharmaceutical companies of the expenditure incurred on drug promotion, and penalty on the company and vetting of drug related material in continuing medical education would be considered."
The Planning Commission says pharmaceutical marketing and aggressive promotion contributes to irrational use of drugs and therefore there is a need for a mandatory code to identify and penalize unethical promotion by pharma companies.
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.
