India: Latest Amendments In 2013 To The Drugs And Cosmetics Rule, 1945

(Insertion of Rule 122- DAB, Rule 122 DAC and Rule 122 DD in the Drugs and Cosmetics Rule, 1945)

Clinical research is the key to the discovery of latest diagnostic methods and to develop modern drugs for treatment of diseases. Last year, the Government had finally given positive node to foreign pharmaceutical companies to invest in India, clinical trial is a very positive requirement to strive towards the growing developments in the present Pharmaceutical market worldwide. With that, the concept of Good Clinical Practices (GCP) has also created awareness in India which is an ethical and scientific quality standard for designing, conducting and recording trials that involve the participation of human subjects. However, in India how far such practices are a reality was a big question till some time back.

Unfortunately, till some time back, the provisions of compensation to the vulnerable subjects who suffer injury or death during participation in clinical trial of a new drug which targeted to be launch in the market by Pharma companies were silent and not covered under the Drug and Cosmetics Rule, 1945. However, the insertion of the new Rules 122-DAB, Rule 122-DAC and Rule 122 DD vide first, second and third amendments respectively have been able to fulfill the lacuna of the need of such compensatory provisions.

Insertion of Rule 122- DAB in the Drugs and Cosmetics Rule, 1945 (called as The Drugs and Cosmetics (First Amendment) Rules, 2013.2

Rule 122-DAB (1) lays down the requirement of providing free medical management as long as required, in the case of an injury occurring to a clinical trial subject. Further if the injury suffered by the trail subject is related to the clinical trial conducted on such subject, he or she shall also be entitled for financial compensation as per order of the Licensing Authority. In case the clinical trial results in the death of the subject, financial compensation, as per the order of the Licensing authority, has to be compensated to the nomiee (s) of the deceased subject. The preceding subsections of the Rule explain the circumstances which is considered as a "direct nexus" to an immediate cause to the injury/death, consequences of non-payment of compensation, etc.

Insertion of Rule 122 DAC in the Drugs and Cosmetics Rule, 1945 (called as The Drugs and Cosmetics (Second Amendment) Rules, 2013.3

Rule 122 DAC specifies the prerequisites required for a clinical trial to be considered as adequate so as to grant permission by the Licensing Authority to be conducted on any human body. Further the rule lays down the power of the Licensing Authority to impose any additional conditions to be fulfilled in case of grant of permission in respect of any specific clinical trial, as it is deem fit.

Insertion of Rule 122 DD in the Drugs and Cosmetics Rule, 1945 (called as The Drugs and Cosmetics (Third Amendment) Rules, 2013.4

Rule 122 DD deals with mandatory registration of the Ethics Committee and specifies that no Ethics Committee shall review and accord its approval to a clinical trial protocol without prior registration with the Licensing Authority as defined in clause (b) of rule 21 and describes the procedure of such registration to be made by filling an application to be made to the Licensing Authority in accordance with the requirements as specified in the Appendix VIII of Schedule Y of the Rule and the procedure thereof.

Conclusion

As India is approaching towards globalization in the recent developments in the Pharmaceutical sector occurring worldwide, India portrays to be a prospective hub for many big foreign Pharmaceutical Companies for drug innovation, based on its comparatively low cost and skill base, so as to exploit this opportunity for the betterment of the country. However, all these while India was failing to implement a rigid and stricter vigilance mechanism on the Pharmaceutical Companies who conduct such clinical trial at the cost of the lives of some vulnerable and poor individuals who are not even aware that in our Country there is existence of "right" to lead a safe and healthy life. To conclude, with the insertion of the rules has brought light of hope to many of those vulnerable ones and it is expected that the concept of Good Clinical Practices (GCP) will be a reality and not just on papers.

Footnotes

1. http://www.livemint.com/Politics/D0gBgwCn3huK72S06p8K5H/The-dark-underbelly-of-Indias-clinical-trials-business.html

2. Vide Notification of the Government of India, Ministry of Health and Family Welfare (Department of Health) number G.S.R 53(E) dated 30th January 2013 in the Gazette of India

3. Vide Notification of the Government of India, Ministry of Health and Family Welfare (Department of Health) number G.S.R 63(E) dated 1st February 2013 in the Gazette of India

4. Vide Notification of the Government of India, Ministry of Health and Family Welfare (Department of Health) number G.S.R 72(E) dated 8th February 2013 in the Gazette of India

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