Relaxation and modification of the regulations to streamline

regulatory approvals in India

India has grown steadily as a preferred hub for conducting clinical trials. Thanks to the
amendments made through the years to the Drugs and Cosmetics Act and Drugs and
Cosmetics Rules.

What is the Drugs and Cosmetics Act?

The Drugs and Cosmetics Act came into being in the year 1940, and has Chapters, Rules
and Schedules to regulate the quality and safety of drugs imported, manufactured and
distributed in the country. This Act also saw the establishment of Central Drugs Standard
Control Organization (CDSCO), and the Drugs Controller General of India (DCGI), the
regulatory authorities to monitor drugs and clinical trials in India. These authorities are
similar to the United States Food and Drug Administration (US FDA), Health Canada and the
European Medicines Agency.

It has 12 appendices, including formats for clinical trial protocols, informed consent forms,
ethics committee (EC) approval templates, and serious adverse event (SAE) reporting.

What are the Drugs and Cosmetics Rules?

Drugs and Cosmetic rules were set in 1945, and is the central legislation regulating India's
drug and cosmetic import, manufacture, distribution and sale.

What is Schedule Y?
Schedule Y of the Drugs and Cosmetics Act is what governs the clinical research industry in
India.

What amendments have been made to Schedule Y?

The Schedule Y first saw major amendments in the year 2005 which was an attempt to bring
the regulatory standards for clinical trials in par with the international standards. This
schedule has been time and again revised, modified and relaxed to ease the approval
process for clinical trials in the country.

From setting a definition for clinical trials to setting up an online portal for easy submission of
applications to clinical trials approval, CDSCO has taken up several initiatives to modify the
Drugs and Cosmetics Rules, 1945. This has reduced the number of layers/steps involved in
the approval process, making it faster without compromising the safety, quality and
performance of the products.

The period between January 2017 and June 2017 itself has seen many changes to the
guidelines regulating the drugs and cosmetics in India. A few of such amendments related to
clinical trials include:
Obtaining import licence has been made easy.
 The results of bioequivalence study can be submitted along with the application for grant
of a licence of oral dosage form of drugs specified under category II and category IV of
the biopharmaceutical classification system.

Some of the important amendments made to the regulatory laws governing clinical trials in
India, in the recent years include:
Prior approval for the import or export of human biological samples for lab analysis/R &
D testing has been relaxed.
Issue of no objection certificate (NOC) or permission for conducting clinical trials is now
done by the Drug Controller General of India (DCGI). The process has been simplified as
well.
Audio-visual (AV) recording of Informed Consent Process (ICP), which was made
mandatory for all clinical trials in 2013, is now mandatory only for vulnerable subjects in
trials of New Chemical Entity (NCE)/New Molecular Entity (NME), anti-HIV and anti-
leprosy drugs.
Certificate of Pharmaceutical Product (COPP) needs to be enclosed along with the
application for obtaining registration certificate (RC) as per European or USA guidelines
etc., or information and undertaking required to be submitted under schedule D(I) and
D(II) by manufacturer with the application for registration certificate.
New Drug permission holders must mandatorily have a pharmacovigilance system in
their organization.
Certified quality management system (QMS) has been introduced at CDSCO
headquarters and zonal offices for transparency and accountability in the application
approval process.
SUGAM, an online portal for submission of applications, has been introduced as part of
e-governance.
The application review process has been reduced from earlier existing 9 months to 4
months now.
The test licences are issued within 10 days of submitting the application. This was earlier
issued in 45 days timeline.

If you are looking at doing your research in India, this is one of the best times for regulatory
approvals.

References:
http://www.ijaweb.org/article.asp?issn=0019-
5049;year=2017;volume=61;issue=3;spage=192;epage=199;aulast=Gogtay

http://cdsco.nic.in/writereaddata/Notice%20regarding%20streamlining%20the%20regulatory
%20procedures.pdf