Ahmedabad based Consumer Education and Research Centre (CERC) has urged Mashelkar Committee to introduce a system making drug authorities accountable for not performing their statutory duty.
The CERC was highly critical of the lapse on the part of the drug regulatory authorities to take action against blatant irregularities that are taking place before their eyes. It has produced before the committee a list of brands of pharmaceuticals that do not conform with the parameters stipulated by Indian Pharmacopoeia. All these were tested by CERC as per the parameters laid down by IP or other agencies.
Prof Manubhai Shah, chairman emeritus, CERC wondered that when authentic information by names of the companies and the brands regarding various pharmaceuticals is published by CERC from time to time, how and why the regulatory authority at the centre and state level do not seem to be taking corrective action. He wanted the Mashelkar committee to see why such valuable and authentic information is not being acted upon and what remedial measures the committee proposes to take.
"We have to remember one basic feature concerning pharmaceuticals particularly when the medicine is prescribed for a serious ailment. If any medicine is ineffective or action is delayed, such medicine is interpreted by the courts not as ineffective, but as unsafe. The rationale underlying the same is that doctor prescribed medicine to the patient on the assumption that the medicine shall work. If it does not, the ailment of the patient gets aggravated and it can even lead to serious consequences. It is in that context that ineffective or slow action medicine is interpreted as unsafe", he explained.
As pharmabiz had reported, CERC 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 had 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.
Similarly CERC had also cautioned about the toxicity of Cisapride, dangerous side effects of anti-smoking drug Bupropin, questionable bioavailability of Knoll Pharma's anti-epileptic drug brand Eptoin, serious side effects of Phenylpropanolamine and inadequate labeling and absence of warnings on Paracetamol brands, several anti-malarial, IV fluids, injectables, vitamin products, eye drops etc.
All the tests were conducted in-house. The CERC laboratory is India's first inhouse comparative consumer product testing laboratory. The laboratory currently tests products in the categories of food, pharmaceuticals and electrical appliances. The laboratory tests products against the Indian and international standards. It also rates and ranks products based on their conformity to standards and on parameters devised in-house.