The Drug Controller General of India (DCGI), in a directive issued on July 20, has instructed all the local drug control authorities in states and Union territories to stop granting approvals for the 'first time fixed combinations' forthwith. This authority, thus, will now be with DCGI's office only. As per the provisions of the Drugs and Cosmetics Act, the power to grant manufacturing and marketing approvals for a new drug is with DCGI. And any new fixed dose combination is also considered to be a new drug and therefore permission for marketing of new combinations should be granted by the DCGI. Yet, several local authorities especially in northern and eastern regions have been issuing licences for the manufacture and marketing of these combinations without exercising any restraint whatsoever. Thus, many of these combinations have no therapeutic rationale, but are freely available all over the country. Irrational combinations are largely noticed in segments like antibiotics, gastrointestinals and opthalmics. An approval from any state or Union territory enables the drug units to market the combination throughout the country. And, the pharmaceutical companies of all sizes, including respectable ones, have been taking advantage of the situation and obtaining marketing permissions from states where drug control establishments are weak and corrupt.

No doubt, this trend is endangering lives of millions of people in the country besides bringing a bad name to India's pharmaceutical industry. The action of DCGI although belated, needs to be therefore appreciated. Probably this is only the first step of the Central Drug Standard Control Administration (CDSCO) to bring in some order in the matter of granting permission for fixed dose combinations. It is extremely important to assess the level of toxicity, patient compliance, degree of side effects, etc. of the new combinations on the patients before they are allowed to be marketed. Most of the local drug control authorities in the states and Union territories are definitely not competent enough to decide therapeutic rationale of drug combinations at this stage. It is therefore just appropriate to vest such powers with a central authority like DCGI which is being regularly assisted by bodies like the Drug Technical Advisory Board and Indian Council of Medical Research. In fact, there is a need for strengthening the entire CDSCO considering the crucial phase of growth waiting for the Indian drug industry in the coming years. This has also been underlined by the Mashelkar committee in its report submitted to the government.