Indian Society of Clinical Research calls for notification of Schedule Y-1 Amendment

According to Indian Society of Clinical Research, The Union Government should notify amendment to Schedule Y-1 without delay so as to make registration of clinical research organizations mandatory in the country.

Dr Arun Bhatt, president, Indian Society for Clinical Research and president, ClinInvent Research India Pvt Ltd, said that amendment to Schedule Y is the need of the hour and ISCR has worked on the revised guidelines and made a submission to the Drugs Controller General of India (DCGI) in September 2009. Only a speedy tabulation of the guidelines could provide the industry the much needed fillip.

"The Schedule Y 1988 was relevant to the generic industry. With the advent of the Good Clinical Practices (GCP) trials since 1995, and adoption of IPR regime in 2005, the country needed to integrate practices of global clinical development. There was also need for legal support to GCP guidelines to improve the quality of clinical trials and we amended Schedule Y in 2006," said Dr Bhatt. "We are now awaiting the revised guidelines which will strengthen the clinical trial sector," he said.

Currently, the clinical trial industry is in a phase of chaos as issues need to be addressed from an in-house perspective. That is why this industry is now insisting on compulsory regulatory inspections from DCGI. The inspection process will put the sector on the right track and on a global platform, he added.

The guidelines will also provide credible image to those who head the CROs. There will be standard operating procedures in place. Schedule Y1 will also insist on renewal of CROs every five years. The function of the Ethics Committees will also be scrutinized. There is also more clarity needed on the insurance of the subjects and the sites, Dr Arun Bhatt told.

According to Dr. Suresh Menon, past ISCR president and chief scientific officer at Novartis India, India needs to strengthen its regulatory framework in clinical trials. Although the country has a Schedule Y under the Drugs & Cosmetics Act, which deals with regulations relating to clinical trial requirements in India, the current regulatory framework not geared up to keep pace with the new requirements.

The Indian clinical trial industry is valued at US$ 500 million. Clinical trials constitute 60 per cent of the cost of the drug development process. There are around 800 human studies which are being conducted in the country at present with 200 Ethics Committees.