The Drugs Controller General of India (DCGI) recent act of banning of 344 FDCs under Rule 26-A of Drugs and Cosmetics Act (D&C Act) with immediate effect, without allowing the pharma companies any chance to sell the already manufactured products which are in the market, is injudicious, imprudent and unfair as far as the Indian pharma industry and the country’s patient society are concerned, said the Indian Drug Manufacturers Association (IDMA).
IDMA president S V Veeramani said the national regulator has acted quite different from the conventional system that has been followed by the hitherto Union government and his office.
“We are surprised and actually shocked to know that more than 2000 branded products involving these 344 FDCs are now out of sale due to the ban, and that too all at once. These 2000 branded FDCs are being used widely by diabetic, cardiac, asthmatic, psychiatric and other patients suffering from chronic/acute diseases. All these patients are medically stabilized by these combination drugs for years. Sudden prohibition and discontinuation of these drugs will definitely undermine millions of patients depending on essential medications,” he said.
Many of these drugs are cleared/licensed officially by the state licensing authorities under the Drugs and Cosmetics Act and also by the office of the DCGI. Further, these medicines are prescribed to the patients by thousands of qualified doctors, and no adverse reaction has been reported either of efficacy or of safety AND but it is unwise, and it will create shortage of essential drugs, subsequently serious health problems.
According to Mr. Veeramani, DCGI has not only given any opportunity to the industry for personal hearing, but also not responded to the many issues raised by manufacturers in their reply to his show-cause notices. He said in the past government had withdrawn 94 products, and the whole exercise was carried out in a systematic, careful and judicious manner so as to avoid hardship to all concerned.
Veeramani also said that now many countries including USA are moving towards FDCs to reduce medical costs for the benefit of the common public, but our country is going in the opposite direction. Another negative point he raised is that this immediate prohibition will help question the credibility of the Indian pharma industry and it will adversely affect the image of the country.