Ref. : ER/Press/’03/nhrc.50/sam

Sale of Unsafe Drugs Violation of Human Rights : NHRC

The National Human Rights Commission (NHRC) has described the manufacture, distribution, and sale of unsafe drugs and medical devices as a violation of human rights. For the first time, the Commission, under the chairmanship of the former Chief Justice of India, Justice Dr. Anand, expressed its views on the issue and announced its course of action at a meeting in New Delhi on Friday 21 November 2003.

Prof. Manubhai Shah, Chairman Emeritus, Consumer Education and Research Centre (CERC), Ahmedabad, was invited by the Commission to make a presentation. He lauded Hon’ble Justice Dr Anand’s leadership of the Commission and appreciated it for having taken note of the in-house comparative testing of medicines and medical devices by Consumer Education and Research Society (CERS), which was promoted by CERC in 1986. CERS disseminates the test findings through its bimonthly, INSIGHT - The Consumer Magazine, and the regional as well as the national media.

Prof Shah said that the medicines which fail to perform in given parameters should be considered unsafe. Eye drops failing for sterility, syringes and needles lacking in cleanliness and carrying particulate matter were unsafe. The anti-epileptic drugs not yielding results in a stipulated time and sterile water for injection which contained endotoxin were unsafe. These tests were conducted at CERS laboratories, Prof Shah added.

He pointed out that the wholesale prices and label prices of pharmaceutical products often varied widely. When a Trust-run Hospital in Ahmedabad started purchasing medicines in bulk from the manufacturers, it was found that the prices of medicines in the retail market were 400 per cent higher than the wholesale prices, indicating the presence of middle men. CERS drew the attention of the National Pricing Policy Authority to the excessive trading margin.

Prof Shah, at the NHRC meeting, insisted that Ayurvedic medicines should be subjected to the same methods of testing as applied to allopathic drugs. He said that there could not be any compromise on the safety of medicine and hence the demand for a check on Ayurvedic preparations in the same way as allopathic drugs are tested.

Prof Shah said ‘Suvarna Vasant Malti’ — a popular Ayurvedic preparation — contained 70 times more lead than WHO’s parameters. CERS tested the preparations and complained to the State Commission, demanding a ban on the drugs, as it would lead to lead poisoning. But the Commission held that allopathic

parameters could not be applied to ‘Suvarna Vasant Malti’, as it was an Ayurvedic preparation. CERS appealed against the order of the State Commission to the National Commission, where the case is still pending.

He also referred to ‘Select’ - an Ayurvedic drug — whose manufacturers claimed that the medicine could influence the sex of the foetus. On a complaint by CERS, initially, the FDA in Gujarat refused to take action as it was an Ayurvedic drug and it was not under its jurisdiction. When the State Health Minister ordered the FDA to take action, the FDA seized ‘Select’ and banned its production. Now, the question is, how could the FDA get the jurisdiction?

The Drug Controller General of India, Mr Ashwini Kumar, told the meeting that the Masalkar Committee, set up by the Central Government to inquire into the issue of unsafe medicine, has finalised its report and is expected to submit it to the Government soon. A copy of the report would be given also to the NHRC which could ascertain what effective measures could be taken on this issue.

About 35 per cent of the medicines sold in the Indian market and 85 per cent of the medicines sold in Uttar Pradesh were found to be spurious, it was revealed at the meeting. Mr Ashwini Kumar said he had faced constraints in controlling such drugs in the market as several States had come out with their own rules and regulations regarding the manufacture of medicines and medical devices.

The Commission announced that a core committee would be formed to make effective enforcement of law and set Standards to govern the testing procedure, licensing, quality and other aspects like manufacture, distribution and sale of medicines in the country.

Besides Chairman Dr Anand, Justice Sujata Manohar, Justice Y. Bhaskar Rao, and Mr. R.S.Kalha, all Members of the NHRC, Health Secretaries of the States of Delhi, Punjab, UP, Haryana, Rajasthan, and Madhya Pradesh, the Drugs Controller General of India, Dr Mira Shiva of the Voluntary Health Association of India, New Delhi, and Dr N H Antia of the Foundation for Research in Community Health, Pune, and Prof K.S.Reddy, Convenor of the Core Group on Health, attended the meeting.

Date : 26 November 2003
Place : Ahmedabad

Pritee Shah
Editor
INSIGHT - The Consumer Magazine

————————————————————————————————
Opinions, test results and research findings issued through this Press Release cannot be used in any form directly or indirectly for advertising, promotional or commercial purpose.

CONSUMER EDUCATION AND RESEARCH CENTRE
“Suraksha Sankool”, Thaltej, Sarkhej-Gandhinagar Highway,
Ahmedabad- 380 054 (INDIA)
Phone: 079-7489945-46 Fax: 079-7489947
E-mail: cerc@wilnetonline.net
Web Site: http://www.cercindia.org
————————————————————————————————-