175 drugs under lens, likely to be outlawed

New Delhi: Over a year after the Central government passed a notification banning the sale and manufacturing of 344 medicines, as many as 175 fixed dose combinations (FDC) drugs are under scanner and may be outlawed for being unsafe soon.

According to the Union health ministry, the experts will start evaluation of 175 FDCs which were declared unsafe and hence put under scrutiny. “The pharma companies dealing with these FDCs were sent notices. Now that we have got their replies, we will analyse the rationale and science which has been cited in support of these medicines by the manufacturers and will take decision on their fate soon,” said a senior official in the health ministry.

The Chandrakant Kokate Committee that was set up in 2014 will review the submissions of the companies before the decision is taken. “These drugs have already been declared irrational due to their high toxicity which may be resulting in anti-microbial resistance. There were issues about their safety and efficacy. Their irrationality were justified with proper references. However, the manufactures have been asked to submit their response. We are now in process of analysing their responses,” added another official.  

Significantly, the Kokate committee will meet on Wednesday to review another set of 120 FDCs that were considered to be rational, but need more data to prove the safety. These manufacturers were asked to generate the post marketing surveillance data. “They were put in Category D, which means that they needed further data generation to ensure that they are safe and efficacious. They may be left with specific restrictions. The meeting on Wednesday is crucial for these 120 FDCs,” added the official.

The FDC drugs are combinations of two or more active pharmaceutical ingredients in fixed ratios, given in the form of a single dose. The decision against the FDCs was taken following a parliamentary committee report that pulled up the ministry of health for failing to rein in large number of FDCs without any approval from the Drug Controller General of India. After examination,344 drugs including painkillers, anti-diabetic, respiratory and gastro-intestinal medicines were banned last year.