Schedule Y: Clinical Trial Regulation in India

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Schedule Y, the current regulator (CDSCO – Central Drugs Standard Control Organization) enforced law in India has been established under Drugs and Cosmetic Act 1945. The regulations to be followed when conducting clinical trials in India are clearly documented to a large extent in this document. Schedule Y for India is a law and not a mere guideline. The enforcement that came into existence in 1988 was an essential provision for providing support to the upscale of generic pharma scenic present in those days. With the entry of large pharmaceutical companies along with the multiple multinationals in field of clinical research the needs changed and a revised version of Schedule Y in line with ICH-GCP (International Council of Harmonisation and Good Clinical Practice) standard was put forth in 1995. Since then multiple revisions to schedule Y took place to provide a healthy environment for clinical research to be conducted in India.
With the recent advancements in its operations, DCGI (Drugs Controller General of India) has taken multiple steps to steer the clinical research industry in the right direction…Steps such as registration of contract research organizations (CRO’s) with DCGI, auditing clinical trials during their conduct, creating guidelines for ethics committees to operate cleanly, and many such proposed ideas will surely help Indian clinical research industry to boost itself. Implementation of these, raises the bar for the industry to function as per quality standards expected by the foreign regulators. Mandatory registration of clinical trials in Clinical Trial Registry of India (CTRI) has already made the process transparent and evolved it to the next level.

The evolution of regulatory systems will help India to tap its potential in unmarked areas like neutraceutical and drug development in herbal (alternative) systems of medicines. DCGI still has several concerns towards creating a better law enforcer, a better Schedule Y which will happen with further revisions of the Schedule Y document in future. The pillars in conducting research such as ethics committees and informed consent are to be strengthened to maintain the patient safety along with collection of quality data. A vigilant, and evolving robust regulatory system is the need of the hour for current regulatory scenario to benefit.
Some highlights of Schedule Y in terms of its appendices; which provide the guidelines to conduct clinical trials are:

Appendix V – Informed consent
Appendix VII – Undertaking by the Investigator
Appendix VIII – Ethics Committee
Appendix X – Contents of Protocol
Appendix XI – Data elements for reporting SAE

There are also appendices detailing a checklist for informed consent documents and the format for informed consent form.
Till recent times, the basic responsibility of Good Clinical Practice compliance used to lie with the sponsor alone, however, with the current advancements in Schedule Y, GCP compliance is turning out to be a shared responsibility of all stakeholders such as the sponsor, investigator, regulatory authority and ethics committees.