A parliamentary panel led by Brajesh Pathak, who represents the state of Uttar Pradesh, received the bill on September 9 with a mandate to examine the amendment and report back in two months.
The altered bill, which was presented before the House on August 29, will introduce more comprehensive provisions for regulating clinical trials and exports.
It will also centralize the licensing of drugs and introduce tighter regulations for medical devices.
In a public statement, the panel commented: “In order to have wider consultations, the committee has decided to invited written memoranda containing the suggestions, views and comments of individuals, institutions and organizations interested in the subject matter of the bill.”
A “central drug authority”
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.
The amendment is being evaluated by the parliamentary standing committee on health and family welfare.
Amongst others, the group is taking in the views of the secretary of the department of health and family welfare.
The committee recently released a scathing criticism of the Union Health Ministry for failing to take action regarding irregularities found in clinical trials in India.
In a report, the group noted: "The Ministry agrees with the Committee's viewpoint about review of approvals to ensure safety of patients, fair play, transparency and accountability.”
“But instead of taking strict and immediate action in all proven cases of delinquency and ommission and commission, it still continues to be in a state of profound procrastination.”