EASE OF DOING NEW DRUG APPROVAL BY CDSCO

Mohammad Shahbaz Alam

New Delhi: Narendra Modi, PM of India had given directive to all ministries just after joining
the post to follow ease of business means fast clearance from government offices. PM
strongly conveyed message to all government servants to implement TQM (Total Quality
Management).TQM means clearance should be on fixed timeline and there should not be
any excuse what may come.
In an attempt to ease norms for testing and introduction of new medicines in the country, the
CDSCO has taken steps to fast-track approvals for clinical trials as well as launch of drugs
already approved in other countries. Pharmaceutical companies planning to launch new
drugs already approved outside India after conducting pre-clinical or toxicological studies on
animals will not be required to repeat such studies in India for importing or manufacturing
them here unless some specific concerns are raised, the Drugs Controller General of India,
under the health ministry, said in a latest circular issued this week.
The drug regulator has also given more freedom and responsibility to the ethics committee
-that monitors clinical trials for new medicines. As per the new norms the Ethics Committee
is expected to cut timelines for launch of new medicines including biologics.
Ethics committee has also been allowed to add trial sites and investigators without the need
to obtain a no objection certificate from the DCGI. However, companies will have to inform
any changes to the DCGI. The move comes in the wake of concerns raised by the industry
which complained of repeat tests and data submissions to different authorities. Of late, the
regulator has also been cautious on approving new drug trials after the Supreme Court's
directive asking the government to ensure patient safety while approving clinical trials. The
recommendations to ease the norms for additional tests were made by the Investigational
New Drug Committee and Drug Technical Advisory Board.
Apart from commercial testing and research, norms have also been eased for academic
research. Making it easier to conduct clinical trials for academic and research purposes that
are non-regulatory in nature the DCGI has said its permission will not be needed provided
that the trials are approved by the ethics committee. However, the regulator can raise
objections if there are any concerns highlighted.
Dr.Surender Singh, first visionary DCGI had introduced TQM and there was fixed timeline for
approvals and it was displayed on website. Timeline had been removed from website after
his regime. Dr.G.N.Singh should continue the legacy of Dr.Surender Singh specially for the
timeline of approvals.
For new drug or subsequent new drug approval only dossiers are required by CDSCO for
approval apart from clinical trial, B.E study and toxicity study. All countries small or big
require sample of finish formulation along with dossier for laboratory analysis. Laboratory
analysis confirms that information given in dossier is real. This will prevent forge data
practice and it will also save the time of regulators. Giving approvals without laboratory
analysis of finish formulation is not justified because medicine is double edged sword either
kills life or saves life depending upon concern during and after approval.
On the other hand PSUR (Periodic Safety Update Report) should be implemented strictly to
maintain the safety of medicine. PSUR submission is mandatory in CDSCO every six
months after approval for two years and then yearly basis.Form-29 or test license is really
not required in case of subsequent approval if manufacturers are submitting finish
formulation sample for laboratory analysis.
Ease of doing new drug approval is really a great initiative and need of the hour. It is time to
lead global healthcare system because population of India is 1/6 th of the world.
Email:medicarechief@gmail.com