India Talks Up Regulatory Revamp
This article was originally published in The Tan Sheet
Executive Summary
Under serious pressure, the Indian health ministry has laid out a plan to modernize the regulatory system at both the central and state level.
The Indian government is accelerating plans to strengthen and modernize the regulatory infrastructure at the central and state levels.
The move, the Ministry of Health and Family Welfare says, will “facilitate expeditious consideration and faster decision making and testing of medical products wherever required and serve the objective of the quality, safety and efficacy of the drugs and other medical and cosmetic products.”
A Dec. 10 notice from the ministry said strengthening the central regulatory system will require an estimated INR9 billion ($144.6 million) and the state system will require $134.1 million. The contribution from the state government is excluded from the central allocation.
The funds form the residual portion of the financial budget assigned over a five-year plan period between 2012 and 2017.
At the central government level, the plans include strengthening of drug safety infrastructure at the Central Drug Standard Control Organization, establishing an advanced training academy and installing an e-governance mechanism and networking of the CDSCO and the state drug control departments.
The CDSCO is the office of the Drug Controller General of India, the top authority responsible for drug approvals in the country. The CDSCO will likely set up new drug testing labs and upgrade existing ones in addition to creating new lab and regulatory affairs positions.
The Indian drug regulatory system has come under sharp criticism from health activists as well from senior level ministers who have accused regulators as responsible for shortcomings and the questionable quality of drugs approved for marketing.
The issue of strengthening India’s regulatory mechanism comes against the backdrop of the recent deaths of 13 women at a sterilization camp in the state of Madhya Pradesh (Also see "India: Of Bad Drugs, Deaths And Promises Of Reforms" - Scrip, 24 Nov, 2014.).
Additionally, pressure has mounted on the DCGI over the last few years, with critics saying the inspection procedures for manufacturing facilities need an overhaul and training to match the global standards of regulatory practices.