The Karnataka pharma industry sees that the ban of 344 fixed dose combination (FDC) drugs will dent its year-end profitability. The earnings from these drugs have suddenly stopped and the companies have to look at speedy recall of stocks.
The government has taken the industry by surprise by banning these 344 drugs all of a sudden is viewed to be catastrophic. This is because in January 2013, the government had called for safety and efficacy studies of FDCs. Most companies from states like Pondicherry, Tamil Nadu, Uttaranchal and Himachal Pradesh were not sure if the data on their drugs would be acceptable. But companies in other states submitted the required data. Despite complying with the Drugs Controller General of India (DCGI) directions, products of companies which came forward and submitted safety and efficacy data are now banned whereas products of companies who have not submitted safety and efficacy data continue to be marketed. Therefore, it comes in as double edged sword for the pharma industry in the country, noted industry heads.
“We are now waiting to see how the government work to reverse the move because companies are holding a valid license and many have gone to court to prove their point. It also needs to be seen how the government will identify irrational products for which safety and efficacy data were not submitted and these products continued to be manufactured based on permissions issued by state drugs control department, they said.
According to Sunil Attavar, president, Karnataka Drugs and Pharmaceutical Manufacturer’s Association and managing director, Group Pharma, weeding out irrational combinations is a good move but many of these drugs were approved by the DCGI.
“We are in a state of quandary because many of these drugs are permitted officially by the DCGI, some as recently as last month. Also, a circular from the DCGI office had clearly indicated that for drugs manufactured prior to 1988, pharma companies did not have to file safety and efficacy studies. Now some of these drugs still figure in the list of 344 drugs banned,” said Attavar.
Sunil Mundra, managing director, Natural Capsules said the move to ban 344 FDCs has directly and indirectly hit the pharma industry. With the result the profitability of pharma industry takes a beating. This has hit our business sentiments and is a big setback to our customers as we supply capsules to most of these formulations.
There are vitamin combinations like vitamin B1, B6 and B12 which are banned. What could come about is the manufacture of individual dosage forms by pharma companies to drive single ingredient therapies which was precisely what the regulatory authority wanted. This will see doctors to probably prescribe multiple drugs under the vitamin category, noted Mundra.
The FDC ban does not affect us, but on the industry there is a sizable impact. We do see companies moving to court. Therefore there is no stopping of sale for these companies until such time the matter comes in for hearing, said Shailesh Siroya, managing director, Bal Pharma.
We are with the government to weed out proven irrational combinations from the market. The impact to our company is minimal and is about 3-4 per cent of our annual turnover. We will work with the regulators to identify and launch safer alternatives, said Harish K Jain, secretary, KDPMA and director, Embiotic Laboratories.