New name, more say for drug regulator

Written by Soma Das | New Delhi | Updated: Sep 20 2012, 07:49am hrs
The Drug Controller General of India's (DCGI) office may soon get a new name and a broader mandate to include drug exports.

The office is also likely to be rechristened as the Drug Regulatory Authority of India like the Telecom Regulatory Authority of India (Trai). Although the drug regulator is more commonly known as DCGI's office, its legal name is lengthy and protracted Central Drug Standard Control Organisation (CDSCO).

Additionally, the sway that it holds over R62,000-crore domestic drug market may be expanded to include exports, which is pegged at another R60,000 crore for the Indian drug industry.

Currently, the DCGI's jurisdiction is restricted to 'imports, manufacture, distribution and sale of drugs in India even though it issues no-objection certificates (NOC) to drug exporters provided they meet certain basic conditions.

An entire chapter devoted to exports with rules framed would be made part of the Drugs and Cosmetics Act, a senior health ministry official said.

He added that proper caution would be taken to not encroach upon the scope of the ministry of commerce and there would clear demarcation in the remits of the two arms of the government. These changes are expected to be part of amendments to Drugs and Cosmetics Act, which are likely to be introduced in the next session of Parliament.

In addition to this facelift, the drug regulator may get a real powerlift, if the health ministry's proposal of facilitating linkages between central drug regulator and state drug regulators in 12th five-ear plan gets a go-ahead from the planning commission and national development council.

The health ministry has sought a grant of R6,256 crore from the plan budget to strengthen the drug regulatory framework of the country. If accepted, the ministry plans to provide financial and human resource assistance to states alongside helping them create new labs and upgrade existing ones.

A total of R3,200 crore is being envisaged to be spent on consolidating the state drug regulators, a part of which would be shared by the state. Besides adding specialised labs for testing drugs, diagnostic kits, cosmetics, medical devices, major components of expense include adding manpower, and an efficient pharmacovigilance system a mechanism to monitor adverse drug effects.

Role reversal

* The Drug Controller General of India will be rechristened as the Drug Regulatory Authority of India

* It will ge a broader mandate to include drug exports, pegged at R60,000 crore

* Changes are expected to be part of amendments to Drugs and Cosmetics Act, likely to be introduced in the next session of Parliament