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Year : 2013  |  Volume : 4  |  Issue : 3  |  Page : 155-156

Impact of recent regulations

Regulatory Affairs, Reliance Life Sciences Pvt. Ltd.,Navi Mumbai, Maharashtra, India

Date of Web Publication22-Jul-2013

Correspondence Address:
Bobby George
Reliance Life Sciences Pvt. Ltd., Dhirubhai Ambani Life Sciences Centre, Rabale, Navi Mumbai - 400 701, Maharashtra
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2229-3485.115369

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How to cite this article:
George B. Impact of recent regulations. Perspect Clin Res 2013;4:155-6

How to cite this URL:
George B. Impact of recent regulations. Perspect Clin Res [serial online] 2013 [cited 2023 Mar 30];4:155-6. Available from: http://www.picronline.org/text.asp?2013/4/3/155/115369

Keeping in line with the apex court's directives, the Ministry of Health and Family Welfare (MoHFW) has off late come up with strong confidence building measures to protect the rights of the subjects participating in clinical trials (CTs), by notifying three back to back amendments to drugs and cosmetic rules namely Rule 122 DAB (first amendment), [1] Rule 122 DAC (second amendment) [2] and Rule 122 DD (third amendment). [3] Though these steps have been in the right direction, at the same time these have raised challenges for the pharma/device/biotech industry/Contract Research Organizations (CROs)/academic investigators and regulators themselves, all of whom have had to realign themselves with the requirements, which are now mandated. Investigators and their teams, the sites ethics committees (ECs) and the site/institutional heads/chairman all have got additional responsibilities as part of their scope. While, 450 odd ECs have got themselves registered so far, many have not been that fortunate. The unregistered ECs cannot legally review and accord their approval for CT protocols. This has led to delays in study initiation at those sites and crippled recruitment projections for approved CTs from the licensing authority (LA). Going forward, it would be advisable for sponsors/CROs to select sites, which are affiliated to registered ECs, rather than risking unregistered sites as part of the study. Approvals being issued for CT protocols have a binding on the applicant to abide with the new rules. This has triggered amendments to informed consent documents and their submission to ECs and LA. Changes in adverse event reporting requirements have forced investigators and ECs apart from the sponsors/CROs to be more vigilant and sensitive to the issue. They need to spend more time on each case than what they used to do in the past and report the event as per the defined process within the stipulated timelines. With time bound actions to be taken for serious adverse events (SAE) leading to CT related injury or death (including issues around compensation), all stakeholders need to have to proper systems in place to ensure compliance. There have been some debatable issues in Rule 122 DAB like provisions of compensation to be provided in case of failure of an investigational product to provide intended therapeutic effect (lack of efficacy); administration of placebo providing no therapeutic benefits or adverse effects due to concomitant medications, which need further clarification. Detailed risk assessment study plans need to be chalked out by sponsors to factor compensation related risks. Probability that people may get lured by economic incentives to participate as subjects in CTs have risen. The sponsors and insurance providers are revisiting the type and level of insurance and indemnity cover needed or which can be provided for the on-going and future CTs. The extent of documentation to be maintained at site, EC, sponsor, CRO and at LA end has grown multi-fold with these rulings.

Until a couple of years ago, India was being perceived as one of the preferred destinations to do CTs. Not any longer! Companies and CROs engaged in clinical research and institutes conducting these programs are facing stagnation at least for an interim period. Even the number of study feasibilities being either requested/conducted in the phase II and III CT settings has significantly come down. CROs having dedicated groups for conducting such feasibility studies are liquidating these groups and allocating them different job profiles. CROs engaged in doing bioavailability/bioequivalence studies who had been relying on independent ECs have also been affected by these new rulings. With the registration of CTs having been made the law of the land, the non-industry sponsored academic research, trials with traditional systems of medicine and investigator driven trials have slowed down. The number of approved CTs registered in Clinical Trials Registry India (CTRI) website has also been on a decline. One can expect new drugs to be even costlier with the overall spend for conducting CTs going up.

The expert committees constituted by the MoHFW for formulating guidelines, standard operating procedures and approval procedures have been seeking opinion from stakeholders by holding formal meetings in order to come up with an effective policy document. The expert committees are expected to come up systems and processes for establishing long-term solutions and robust monitoring mechanisms. The regulators have clearly shown the will, firmness, conviction and taken action in salvaging the situation in an effort to establish their credibility and build up the public trust in CTs. They have also stepped up on the number of site inspections to monitor the on-going CTs. When the tide is high, some just wait and watch from the shore. Some try to ride the waves and balance themselves. We need to quickly adapt to the new systems and move forward otherwise we would be left far behind!

   References Top

1.G.S.R. 53(E): Drugs and Cosmetics (First Amendment) Rules. Delhi: Published in The Gazette of India, By: Controller of Publications; 2013.  Back to cited text no. 1
2.G.S.R. 63(E): Drugs and Cosmetics (Second Amendment) Rules. Delhi: Published in The Gazette of India, By: Controller of Publications; 2013.  Back to cited text no. 2
3.G.S.R. 72(E): Drugs and Cosmetics (Third Amendment) Rules. Delhi: Published in The Gazette of India, By: Controller of Publications; 2013.  Back to cited text no. 3


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