The secretary general of the AIDCOC, Ravi Uday Bhaskar, has raised objections that centre on the fact that the amendments will limit the powers of the state authorities, by moving the licensing of the 17 proposed critical product categories to Central government.
Bhaskar underlined that this affects challenges by consumers, particularly those for substandard drugs, or manufacturers making spurious claims, and would make the process more complicated and longer.
Expressing reservations over the proposed Bill, the AIDCOC had submitted a representation to Rajya Sabha Secretariat in which they raised strong objections on various provisions dealing with health which comes under concurrent list in Constitution of India. “It will lead to contravening of Article 246,” said Uday Bhaskar.
He mentioned that the Bill seeks to form Central Drug Authority (CDA) headed by health secretary as chairman and Drug Control General of India as member secretary.
Then import, export of simple formulations like paracetamol will also come under the control of the CDA, apart from other policies, he said.
The proposed bill would streamline the process of registering a drug or cosmetic by creating a Central Drug Authority similar to the US FDA.
This body would have the power to review licenses granted to products and suspend and cancel those which did not meet requirements.
The process for registering a new cosmetic or drug with the Indian parliament is currently frustratingly convoluted.
A new product can be approved for marketing by the CDSCO, but a license for its distribution still needs to be issued by individual states.
This situation is made worse by the fact that many local officials do not have the qualifications necessary to evaluate new drugs or cosmetics, and by the high quantities of fake and spurious products on the market.
Although the bill is focused on the import, export, manufacturer and distribution of drugs, the amendments basically propose that both drugs and cosmetics will be regulated by a Central Drugs Authority.
The bill intends to build on the 1940 Drugs and Cosmetics Act, which was introduced under British colonial rule, and has ten times since it was first introduced, the last time being in 1986.
The altered bill was presented to the Indian parliament at the end of August, with the aim of providing more comprehensive provision for regulating clinical trials and exports.
Meanwhile the process of examining the new amendments commenced in parliament in the second week of October, with the aim of making a full report by the beginning of November.