RCGM Requirement For R-DNA Derived Drugs

by Akash Mishra web designer

While genetically modified drugs and foods are showing a strong presence in the global markets. It has become necessary to draft proper rules for drug product registration in India.

In the year 2016 CDSCO or the central Drugs Standard Control Organization (CDSCO) has released new regulations about conductance of the clinical trials. It modified the trial requirements for all sponsors who wish to conduct some clinical trials in India. Moreover, CDSCO has also addressed some matters that might help in decreasing the timelines of clinical trials thereby encouraging active participation.

Changes that have been implemented:

There will be a need for NOC from DCGI for every addition of a novel clinical trial site. If no objection is received from DCGI, it would be considered as permitted by CDSCO.

Limitation to the number of trials per investigator: The effect on the sponsors who are not able to use sites with required patient populations has been addressed. According to the circular, no investigator can conduct more than three trails at a given time.

Necessity of 50 bed sites for these clinical trials: According to the previous norms, no clinical trial was to be conducted at sites having less than 50 beds. This has been revised and from now on, an ethical  committee will scrutinize the trial requirements and deliver the final decision on the suitability of a test site.

The requirement of approval of the Review Committee on rDNA derived drugs.

Every applicant has to submit parallel applications to RGCM and DCGI for obtaining approval to conduct clinical trials that involve rDNA derived drugs. DCGI will review the application and then offer permission for such trials. But only after clearance from RGCM has been received.

Because of these new requirements all procedures like

●       Assigning new sites for study

●       Permission for conducting outpatient-based studies at smaller hospitals, facilitating the research-based investigators to take more trials at smaller sites

●       Decreasing the approval timelines for rDNA based products

will assist in streamlining the clinical trial setup and all continuing operations for importers and manufacturers.

Detailed process of approval for rDNA products

●       RGCM(Review committee for Genetic Manipulation) orders the applicant to provide biosafety data on the GMO and the drugs on a case by case basis.

●       When RGC is satisfied, it recommends GEAC for approving environmental clearance of a recombinant drug.

●       GEAC then directs the applicant to present more data based on the safety aspects depending upon the type of the drug.

●       Based upon the evaluation of this data, GEAC offers approval for environmental clearance of the product and the applicant has to follow all requirements for  product commercialization.

In our country, the rDNA products are either imported or marketed or they are manufactured after proper compliance with all environmental biosafety clearances.

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Created on Apr 23rd 2020 00:50. Viewed 188 times.

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