India’s drug regulator aims to implement various reforms, including streamlining export clearances for unapproved drugs and simplifying the manufacturing licensing process, in an effort to reduce the burden on its workforce, its head said on Thursday.
The agency has only 2,000 officials to oversee over 10,000 drug factories and 1 million pharmacies in India, Rajeev Raghuvanshi pointed out at a conference in Mumbai on Thursday.
“I cannot increase my workforce overnight,” he said. “Whatever we are doing, I have to analyse how do I cut on what we are doing.”
The federal agency plans to streamline the export clearance process by considering an applicant’s past export history, moving away from a quantity and customer-specific exports system.
For instance, if a company exported 100 million Paracetamol tablets (a common analgesic) last year, it would become eligible for a “blanket” no-objection certificate (NOC) for the same amount this year, he explained.
The certificate, however, would only cover products approved for export, not for domestic sale in India.
The simplified export norms, expected to be introduced in the next few weeks, would reduce the number of NOCs issued by the regulator by almost half, compared to the 10,000 issued in the last eight months, he said.
India, which calls itself pharmacy of the world, supplies 40% of generic medicines used in the U.S., 25% of the total medicines used in U.K. and over 90% of all medicines in many of the African countries, Raghuvanshi said.
The regulator will also remove certain licensing requirements for starting research and simplify manufacturing process for drugs used in testing, examination, and analysis in the country.
India’s drug regulators are under pressure to improve oversight of its $42 billion industry, dominated by small players, after Indian-made cough syrups were linked to child deaths in Gambia, Uzbekistan, and Cameroon.
Raghuvanshi said that the regulator would invest 1 billion rupees ($11.5 million) to develop a new digital drug regulatory system that would gather all relevant information, including that of manufacturers and their supply chains, in a single database.
The federal agency is also developing cell and gene therapy guidelines, expected to be made public in two months, and working on revised guidelines for biosimilars to match global standards.