There is an urgent need for India to be self-reliant in vaccines and other life saving drugs. Currently these drugs are mainly being imported from overseas and are not made available to Indian population at affordable cost, said Varaprasad Reddy, vice-president-ABLE and managing director of Shantha Biotechnics.

India can easily come out of this dependence on external sources as the country has well proved its rich scientific talent outside the country. If congenial atmosphere is created, India can achieve excellence in developing drugs that are both life-saving and affordable, he opined.

In his appeal to the Ministry of Environment and Forests, Reddy said that the companies working on recombinant products find the approval process complicated with long chains of approvals right from Institutional Bio-Safety Committee (IBSC) to Genetic Engineering Approval Committee (GEAC) functioning under multiple ministries.

Explaining the intricacies of the current approval process, Reddy said, IBSC with DBT nominee approves project (category I and II) and recommends to RCGM. Then comes the RCGM approval for Category III followed by approval for toxicity study by RCGM subject to animal ethics committee clearance. Animal ethics committee approval is obtained followed by the toxicology studies. ISBC reviews toxicity studies and clinical trial protocols and recommends to RCGM. RCGM approves toxicity reports and recommends to DCGI and GEAC for human trials. DCGI permission for human trials in addition to GEAC permission. ISBC reviews human clinical trial data and recommends to RCGM.

RCGM approves human clinical trial data and recommends to DCGI and GEAC. Next comes the review of human clinical data by DCGI constitute expert committee. DCGI approval for manufacturing and marketing subject to product testing, facility inspection and GEAC clearance. GEAC approval is then obtained. Final manufacturing licence from local drug authority after facility inspection and clearance from product testing from National Laboratory. And finally reaches the stage of commercial launch for manufacturing and marketing of product.

He recommended that all issues are discussed, debated and decisions be taken at one-go. Over 50 advisory committee meetings with one-on-one meetings with the industry representatives should be conducted every year. Regulatory authority should encourage electronic submission as done in other countries for increased efficiency. It should ensure reduced timelines and safeguard the confidentiality.

It is ironical that the time taking for conducting both pre-clinical and human clinical trials is between 7-18 months, whereas the time taking for going through the regulatory clearances of different committees, departments and ministries is between 19-27 months. It means for companies to commercialise rDNA product in India, it takes about four years.

rDNA Expert Committee, constituted by DCGI consisting of the nominees from Ministry of Environment, DBT, ICMR and practicing medical experts should be given the sole authority to examine the clinical trial protocol and to give the permission for conducting clinical trials, he opined.