The long awaited Central Drug Authority should be in place in a few months from now. The Drug & Cosmetics (Amendment) Bill seeking to establish the CDA is expected to be introduced in the Parliament during the monsoon session. The proposed CDA will have a chairman and five members and will have comprehensive powers at the national level to regulate the pharmaceutical sector. Three of the members will be appointed by the Central Government from persons having at least 15 years of professional experience in pharma industry or related fields. All the existing powers of the CDSCO will be brought under the new CDA. The Authority will have DCGI as its secretary and it will be headquartered in Delhi with offices in other parts of the country as and when necessary.
Formation of CDA was contemplated some years ago considering the pace of growth of Indian pharmaceutical industry and its allied sectors over the years. Need for centralizing the drug control administration was felt on account of the urgency in bringing some uniformity in enforcement of various new rules. Various parts of the D&C Act such as Schedule K, Schedule M, Schedule Y, etc. have been amended and elaborated over the years considering the growth needs of this industry. Enforcement of all amended rules under the D&C Act is on state health departments. It has been found that states have been usually lax in implementing most regulations pertaining to pharmaceutical and health so far. This in effect has been making a mockery of the Act and rules in this sector. Licensing of products is one area where there is a lot of confusion prevails in the country today. Not many countries have a loose system of approving a drug for marketing by a Central authority and then issuing licences for its manufacture by multiple federal agencies as in India. The Central government has not cared to change this system so far as the concentration of the pharmaceutical industry in India mainly confined to Maharashtra and Gujarat until recently. During the last ten years the situation has totally changed. Pharmaceutical industry is vibrant in all the 5 states in south while in north Delhi, Punjab, Haryana, Rajasthan, Madhya Pradesh, Himachal, Uttarakhand and Jammu & Kashmir have a large number of pharmaceutical units. Although these states and Union territories are having drug control departments, most of them do not have officials with sufficient competence to evaluate an application before a manufacturing licence is issued. Even if one state drug licensing authority rejects an application for a product on technical grounds, the pharma companies get the approval from another state and market the product all over the country. The reason for uncontrolled growth of irrational and harmful combination products in the market is this. It is extremely important that this practice of irresponsible licensing system should be stopped in a country which is boasting of supplier of medicines to several developed countries. Formation of CDA should bring an end to this as it will be the sole authority to issue product licences in pharmaceutical sector in the country. Enforcement of GMP norms, rules for clinical trials and regulations for good laboratory practices, etc. are some of the key areas CDA will be directly controlling.