The Union government is all set to amend the Schedule Y in a bid to strengthen the pharmacovigilance protocols further in the country. The office of the DCGI has initiated efforts to take a re-look at the current status of the Schedule Y. This regulation, enacted in 1998 and amended in 2005, has provided the necessary boost to the clinical trial business in India.

The proposed amendment will now make pharmacovigilance in post marketing of drugs more stringent. A set of fresh rules are being made to ensure academia and industry partner with the regulatory authority for the management of risks associated with use of medicines.

The amended Schedule Y in 2005 ushered in significant transformation in the clarity of approval for clinical trials. It also indicated responsibilities of sponsors, investigators and ethics committees. Further it has highlighted the mandatory requirement of informed consent.

Regulations in pharmacovigilance are getting evolved in the country. Now with another amendment to Schedule Y on cards, it will streamline the reporting systems to provide a major boost to the clinical research organizations engaged in human trials, Dr Pratibha Nadig, professor, Bilcare Research Academy, Bangalore told Pharmabiz.

Present regulations insist on reporting adverse drug events. However, this would be reworked to focus on post marketing surveillance. There should be a concerted effort on the part of the academia, industry and regulatory authority to generate the reports to assess the risk of drugs to ensure their safe, rational and effective use. There is an urgent need to motivate the investigators in the clinical research organizations on the safety monitoring both during the clinical trials and in the post marketing phase. This is where clinical research training centres like Bilcare Research Academy, Clinical Research Education and Management Academy (CREMA) and the Institute of Clinical Research India (ICRI) are providing dedicated courses in pharmacovigilance which will create an awareness among the students on the proper methodologies and safety reporting in Pharmacovigilance, explained Dr Nadig.

According to Dr Shobha Rani R Hiremath, professor & head, department of Pharmacy Practice Al Ameen College of Pharmacy, Bangalore and Coordinator, National Pharmacovigilance Programme, India has 21 Pharmacovigilance centres. These include two zonal centres at Victoria Hospital, Bangalore and JIPMER, Pondicherry. Besides these, there are 5 regional centres at Mumbai (two), one each at All India Institute of Medical Sciences, New Delhi, Kolkata and Nagpur. In addition to these, there are several periphery centres across the country which report to the Central Drugs Standard Control Organization (CDSCO). While the regional pharmacovigilance offices are connected to the zonal centres that are attached to CDSCO, which in turn is linked to the World Health Organization (WHO).

Major tool of post marketing surveillance is the spontaneous reporting of adverse events on larger and number of patients. Under the National Pharmacovigilance Programme (NPP) which was launched by the Union government in November 2004 has provided a periodic update on safety reports. The NPP is a bench mark for global drug monitoring efforts, stated Dr. Shobha Rani Hiremath.

In a bid to highlight the Pharmacovigilance scenario, the association of Clinical Research Professionals (ACRP) highlighted the extensive expertise available in India. While the CROs have ascertained promising growth opportunities, the available talent is on a learning curve and a good team of experts are required to create systems in place.