Govt starts work on new law for safer drugs

1. Govt Starts Work on New
Law for Safer Drugs
D&C Act likely to see revision in norms related to examination of new
drugs, modes of delivery

2. Contd…
The health ministry is planning a makeover of the laws governing the
domestic pharmaceutical and medical devices industry . The Drugs and
Cosmetics (D&C) Act and Rules will likely see revision in norms related to the
examination of new drugs, systems and modes of drug delivery ,a source
close to the development said. The ministry is in the process of preparing a
draft set of rules for medical devices under the existing Act as well as a
completely new law to replace the 1940 Act, said a senior health ministry
official, who did not wish to be identified.
A new law is expected to be better suited than amendments to
accommodate innovations and developments in pharma and healthcare,
including those in regenerative therapy, the official told ET. It is also expected
to improve ease of doing business for the industries without compromising
on safety, efficacy and quality of treatment here, the official added.

3. Contd…
“All (new therapies and drugs) cannot be catered in a law or rule which remains
stagnant,“ said the official. “We wanted to amend the D&C Act last year, but it was
decided that it would not be very fruitful.“
Through the Rules, the health ministry intends to expand the coverage of medical
devices regulated in the country, the official said, adding that the first draft is ready
and will soon be implemented to test their efficacy before preparing the law.
At the same time, the proposed Rules would operate under the ambit of the
current D&C Act, which still considers medical devices the same as drugs, said
medical device association AdvaMed. This means that more devices would be
notified and inappropriately addressed as drugs, a spokesperson told ET.
The ministry's Central Drugs Standard Control Organisation (CDSCO) recently
notified that it was revisiting the existing Act and Rules, inviting feedback by June
21 on fedback by June 21 on changes required to improve the country's existing
legislation to meet the current regulatory requirements.

4. Contd…
Some pharmaceutical associations, while stating that the ministry may
only amend the existing Act instead of creating a new one, said that the
need for changes to Act was felt as far back as 2008.
Associations like the Indian Pharmaceutical Alliance (IPA) and the
Indian Drug Manufacturers Association (IDMA) speculate that the
government's latest exercise could be a means to update the Bill in
time for the Parliament's monsoon session.
The ministry last attempted to amend the Act through a Bill introduced
in the Rajya Sabha in 2013. The Bill, reintroduced in 2014 and 2015, is
still pending.

5. For Details and Appointment contact:-
Parveen Kumar Chadha… THINK TANK
(Founder and C.E.O of Saxbee Consultants & Other-Mother
marketingandcommunicationconsultants.com)
Email :-saxbeeconsultants@gmail.com
Mobile No. +91-9818308353
Address:-First Floor G-20(A), Kirti Nagar, New Delhi India Postal Code-110015