Marketing licenses for biotechnological drugs as well as those used in clinical trials are being rejected by India’s apex pharmaceutical regulator, known as the DCGI, or Drugs Controller General of India. In the last year they have tightened the mechanism for approval on all fronts for therapeutic agents. Both domestic and multinational companies are facing much regulatory scrutiny and are often asked to make some changes in order to be approved. It started in July 2010, and many applications/licenses were sent back with deficiency letters.
The result is lengthy delays and the industry is beginning to fume. There are constant complaints about the sudden placement of various bureaucratic hurdles they need to jump through before obtaining approval. The DCGI is well aware of the complaints and state that all delays are due mainly to incomplete applications.
If an application for commercialization is submitted to a regulatory agency in a number of developed countries, including the United States and throughout Europe, and is either incomplete or contains post-approval changes, the marketing approval for that specific product will be rejected. However, the response from the regulatory authority will contain a letter of deficiency. This provides the Sponsor the opportunity to rectify any prior mistakes and then approach the DCGI again. While this does cause a delay for approval, companies should be more appreciative of this strategy rather than withdrawing the product for commercialization.
In the past, the DCGI did not scrutinize the applications as rigorously regarding biotechnology products. However, today numerous companies are striving to introduce more products in the fields of medical device, vaccination and biotechnology. The agency believes more scrutiny is required as companies attempt to inundate the market with products. The regulatory tightening assumed over a majority of the biotechnology products has presented itself at the time where the current biopharmaceutical market is said to start creating massive revenue for a number of the major global drug firms. Therefore, the DCGI needs to ensure that all products are safe for consumption resulting in the current delay in approvals.