One factor that has always bothered the Indian pharmaceutical industry is the presence of too many governing and regulatory bodies. Rationalising these departments is long overdue to make things less complex. However, over the past one year, especially during the past three months, industry representatives have been talking about a turf war brewing between the Ministry of Chemicals and Fertilizers and the Ministry of Health and Family Welfare over the realignment of the departments under their purview.
To start with, the Ministry of Chemicals and Fertilizers seems eager to subsume the Central Drugs Standard Control Organization (CDSCO) under its ambit along with the Drug Controller General of India (DCGI). In fact, the Department of Pharmaceuticals, which is under this ministry, has reportedly sent a proposal to the Cabinet Secretariat for shifting the CDSCO, the national regulatory body for pharmaceuticals and medical devices.
The DCGI, too, operates under the health ministry and acts as the regulatory authority on matters concerning approval of new drugs and clinical trials, and patient safety, besides having regulatory control over medicine imports. It is the global norm. Be it in the US or Europe, drug regulators normally report to the health ministry.
The other proposal, equally talked about, is from a group of secretaries. The group has recommended that the Department of Pharmaceuticals and the National Pharmaceutical Pricing Authority or NPPA (part of the department) should be shifted to the health ministry.
DCGI G.N. Singh says, "It is a policy-level matter and as a regulator, I have no comment to offer at this stage."
Ask industry insiders and the general opinion is that instead of moving the CDSCO to the chemicals and fertilisers ministry, it will make more sense to shift the Department of Pharmaceuticals and the NPPA to the health ministry, which should continue to retain the CDSCO (See Table The Web of Governing Structures).
According to industry representatives, this should work well as the Drugs and Cosmetics Act, a major Act governing the pharmaceutical industry, and a couple of other relevant Acts are all under the purview of the health ministry. Besides, the CDSCO is a much larger organisation than the Department of Pharmaceuticals in terms of coverage, control or even annual budget. Also, the health ministry runs a number of schemes through the CDSCO and a shift, therefore, may not be desirable.
But the bigger issue raised by the pharmaceutical units is - what purpose the proposed shift will serve without an overall structure rationalisation.