Amendment to Drugs and Cosmetics Act under consideration
With the number of incidents related to violation of medical ethics increasing, particularly those involving clinical trials by foreign pharmaceutical companies, the Centre has now decided to bring such cases within the purview of law.
The Union Health and Family Welfare Ministry is in the process of amending the Drugs and Cosmetics Act to make violation of medical ethics an offence punishable under law.
This is likely to be done by adding a separate chapter on medical ethics in the Act, that would also prescribe punishment for such offences, Health and Family Welfare Minister Ghulam Nabi Azad told The Hindu.
At present, medical ethics violation cases, such as negligence, are dealt with under various provisions of the Indian Penal Code (IPC).
However, with the number of complaints regarding violation of medical ethics coming in from across the country, such a move has been necessitated.
In a recent episode in Indore, doctors were accused of carrying out clinical trials for a multinational drugs company on patients without obtaining their consent, which is mandatory as per the guidelines of the Drugs Controller-General of India (DCGI). The doctors are also reported to have been given monetary incentives and free foreign trips for carrying out the trials.
Earlier, the Centre ordered suspension of clinical trials on tribal girl students in Andhra Pradesh and Gujarat, carried out by a non-governmental organisation, Path-International, for U.S-based pharmaceutical company MERCK for HPV (human papilloma virus) virus to prevent cervical cancer.
While it is believed permission had been granted for carrying out such trials, there was violation of guidelines on the ground and this became known after some girls reported adverse side-effects. A three-member committee is looking into the matter.
According to Mr. Azad, at present the Ethics Committee — whether at the national, State or hospital level — can only suspend trials in case of violations. If any doctor is directly involved in the trial, his license can be cancelled. “Law does not prescribe any punishment for this offence,'' he said.
The Board of Governors of the Medical Council of India has also set up a working group on medical ethics reforms that would recommend strictures against medical malpractices.
These would be taken into account before finalising the amendments.
Already, the Lok Sabha has passed the Clinical Establishments (Registration and Regulation Act) Bill, 2010 that makes it mandatory for all clinical establishments to provide medical care and treatment to stabilise any person in an emergency condition.
Once the Bill is passed in Parliament, this will be the first time emergency medical care is made obligatory under law in the country.
Accident victims are often referred to government hospitals from private facilities to avoid legal hassles. Particularly, women are turned away from private hospitals and nursing homes at the time of delivery if they fail to deposit money in advance, Mr. Azad explained.
As per the Bill, all clinical establishments will be required to register themselves with the State Council for Clinical Establishments. These include hospitals, maternity homes, nursing homes, dispensaries, clinics and similar facilities with beds that offer diagnosis, treatment or care for illness or injury or pregnancy under any recognised system.
The legislation will help in addressing unregulated growth of the private sector, often accused of inadequate treatment, excessive use of higher technology, medical malpractices and negligence.