Cipla, Pfizar among the 200 to allegedly sell poor quality drugs | DCG of India launches Inspection
Pharma giants like Cipla, Pfizer are found to be among the 200 who are accused of selling poor quality medicines and non-compliance to manufacturing norms. The Drug Controller General (DCG) of India has launched inspections against the 200 drugmakers.
According to an Official from the health ministry, already 36 drug manufacturing plants were inspected over last three months. In the second phase, inspections will be conducted in 20 more facilities.
According to a source, notices have been issued recently to Cipla and Pfizer informing them of the upcoming inspection as well as violations found in their products. Cipla maintained it has not received any intimation so far. Pfizer did not comment.
This is for the first time that the domestic regulator has undertaken the task of inspections on this scale. The move also assumes significance as it comes in the wake of the recent regulatory ban on 344 fixed dose combination drugs.
The government official said that the 200 companies, where “risk-based inspections” are being carried out, have been listed based on three criterion. Regulatory data for the last five years have been analysed
and the companies were listed where violations were reported regularly. Besides, complaints from international agencies and importers of medicines from Indian plants have been considered.The regulator has also drawn drug samples from the market through surveys and gathered inputs from state authorities to identify the firms.
The 36 plants already inspected are based in Tamil Nadu, Uttarakhand, Maharashtra and Himachal Pradesh. The health ministry had also organised special training programmes for drug inspectors to ensure objectivity and transparency.
Indian pharmaceutical manufacturing plants have been on the radar of international agencies. Ranbaxy Laboratories, now part of Sun Pharma, had to stop supplies after the US FDA pointed out major violations. Pharmaceutical exports are expected to cross $20 billion by 2020 from $14 billion in 2016.
