In September last year, a missive from the Ministry of Chemicals and Fertilizers directed the Medical Council of India to investigate 300 doctors for alleged violation of the ethics code.
The ensuing investigation brought into focus the simmering issue of a doctor-drug company nexus. And the niggling worry that such a relationship could lead to irresponsible prescription. Unethical promotions don't afflict only the Indian market or local companies. Large multinationals too are grappling with bribery and fines in different markets.
Pharmaceutical industry voices and doctors advocate self-regulation, stressing on transparency and disclosure to keep interactions above suspicion. But probe a little, and grey areas surface on the fine ethical line doctors walk when appointed as consultants to drug companies.
An ombudsman (public advocate) could be one way for the pharma industry to navigate the not-so-clearly defined ethical path, so complaints can be dealt with transparently, say some representatives, especially since the MCI has no authority over the drug industry. But doctors have a clear medical ethics code, says Dr KK Aggarwal, senior national Vice-President with the Indian Medical Association. They cannot take gifts, favours, cash, grants, hospitality or travel, from a drug company. And transgressions get punished by anything from warnings to disbarment, says Aggarwal. In fact, doctors can work for a pharmaceutical company as consultants, provided there is transparency in the association and decisions are not influenced by the company, he clarifies. Besides, the doctor needs to disclose this association upfront to avoid allegations of conflict of interest.
In the absence of the Government conducting continuing education programmes for doctors, updates on drugs and science come from drug companies. But, the transaction needs to be transparent, financial details should show up on tax statements and there should be no quid pro quo or return favour sought from the doctor, Aggarwal explains.
Amit Sengupta of Jan Swasthya Abhiyan , though, is not comfortable with doctors being empanelled with drug firms. Cruises and gifts for doctors have been replaced by more sophisticated methods, observes Sengupta, referring to doctors becoming consultants with pharma companies.
It may not be illegal, he clarifies, but it sits uneasy and requires clarity.
Ready reckonerRanjana Smetacek, with the Organisation of Pharmaceutical Producers of India (OPPI), a platform largely for multinational drug companies, says that they have a group of adjudicators who examine complaints against members. Last year saw a handful of complaints, largely related to promotions and marketing.
In an earlier stint with a multinational, a 24/7 helpline gave clarity on government rules in nine languages. Smetacek suggests a similar ready reckoner for industry representatives to explain complexities in different regions.
For instance, would a Diwali gift be seen in cultural context (okay with a price cap) or is it an ethical transgression? The OPPI is for a universal code of pharma marketing, she says.
Representing large local players, the Indian Pharmaceutical Alliance is pushing for an ombudsman, says DG Shah, adding that industry should be given a shot at self-regulation before the Government steps in.
But the Government does indeed need to step in and push the ethics issue much higher on its agenda, since it directly involves the health of ordinary, unsuspecting people.