The Consumer Education and Research Centre (CERC), a leading NGO and customer action group based in Ahmedabad, is planning to move the Court against the Drug Controller General of India (DCGI) for not responding to its repeated pleas to initiate appropriate action against unsafe and substandard drugs.

The CERC, which regularly conducts quality tests and analysis of consumer products including drugs had cautioned the drug regulatory authorities and pleaded to DCGI to initiate corrective measures. During the two years, CERC has brought names of several drug products to the notice of the DCGI as they are found with serious quality and safety inadequacies.

Manubhai Shah, Chairman Emeritus, and former Managing Trustee, CERC, who met the DCGI recently to request the Department to expedite its action to prevent unsafe drugs floating in the market and also to look into the matters of inadequate warning and labeling instruction on the drugs, said, "Though we have been persuading the matter seriously, the Department has never responded positively on this yet. Hence, the NGO is left with no option but to approach higher authorities like Parliament, the High Courts or Supreme Court of the country to seek appropriate action."

The customer action group had cautioned the DCGI against the dangerous consequences of allowing preparations of liver extracts in Indian market despite its withdrawal in many advanced countries due to the dangers of animal disease transmission. Since Vitamin B12 is available in direct form, the CERC has urged the ban of liver preparations from the market in a letter dated April 20, 2000 . However, the products still continue in the market as no action was taken by the drug control department.

CERC had also cautioned about the toxicity of Cisapride (letter dated 24.04.2000), dangerous side effects of anti-smoking drug Bupropin (letter dated 25.07.2001), questionable bioavailability of Knoll Pharma's anti-epileptic drug brand Eptoin (letter dated 08. 03. 2001), serious side effects of Phenylpropanolamine (letter dated 08.01.2001) and inadequate labeling and absence of warnings on Paracetamol brands (letter dated 14.05.2001) with several reminders to the DCGI. Despite many reminders and persuasions, the issues remained unresolved.

The CERC sources stated that the office of Drug Controller General of India has the highest responsibility of ensuring drug safety and ethical practices in the drugs and pharmaceutical industry. "Such an office cannot simply get away with some excuses like shortage of manpower, poor infrastructure, to allow unsafe and substandard drugs continue in the market for human use, they added.