Government Mulls Four 'Big-Ticket' Projects To Better Regulate Indian Drugmakers
The projects will help upgrade and upskill the current drug regulatory system.
Four "big-ticket" government projects are in the pipeline to upgrade and upskill the current drug regulatory system, according to Dr. Rajeev Singh Raghuvanshi, Drug Controller General of India, Government of India.
They are as follows:
Developing a digital drug regulatory system across the country.
Rationalising drug regulation.
Formulation of internal scientific cadre at the Central Drugs Standard Control Organisation.
Developing digital IP (intellectual property) for the sector.
The four initiatives have been planned to make the regulatory bodies more efficient in evaluating digital and artificial intelligence-related procedures and spot non-compliance in this space.
According to Raghuvanshi, the government is also planning to hire external consultants to examine the Central Drugs Standard Control Organisation's internal and external processes, and two consultants will commence work in July.
"Moreover, about 250 additional inspectors are already under requirement process," Raghuvanshi said at the two-day 9th Pharma Global Quality Summit in Mumbai on Thursday, addressing the need to improve the government's drug regulatory system.
The move comes at a time when Indian pharmaceutical and healthcare companies are acknowledging the importance of further digitisation and artificial intelligence in manufacturing and other processes. Industry players think further digitisation and incorporation of artificial intelligence can aid in better monitoring of cleaning processes and maintenance of tools, violations of which are a major concern for Indian drugmakers, according to the US Food and Drug Administration.
"One of the things that we see is an issue around cleaning and maintenance of equipment; you take a look at firms (inspection), and you see white powder and scratches (on the equipment); this is cited the most," said Kellia Hicks, Consumer Safety Officer, India Office of the US FDA.
According to the regulatory body, Indian drug manufacturers must frequently clean and change equipment, as non-compliance may hinder the drug-making process.
What Are Companies Saying?
Ranjana Pathak, president and chief quality officer at Lupin Ltd., spoke of the challenges involved. "Using the same facility for multiple molecules is a big challenge. Some are hard to clean, some are not, so that challenge is immense," she told NDTV Profit. "We're trying to battle with it, but we haven't mastered it. We need help from equipment manufacturers to check the design and cleanability of the equipment."
"I think evolution in the cleaning process has not kept pace with evolution in manufacturing practice. It is still considered an extra (separate), outside of manufacturing activity," said Krishna Venkatesh, head of global quality and pharmacovigilance at Dr Reddy's Laboratories Ltd.
According to him, active pharmaceutical ingredient makers are better at developing and following cleaning procedures, and Dr. Reddy's Labs has become more automated and is trying to keep track of regular cleaning.
Domestic industry body Indian Pharmaceutical Alliance had also emphasised how equipment cleaning and maintenance norms were violated over a decade ago, even though the core manufacturing norms are better complied with.
As per the data shared by the IPA on Wednesday, gaps in practices, maintenance of facilities, and ancillaries versus the written procedures have risen to 23%, despite a drop of 3–4% in violations found in capability, training, lab controls, and core manufacturing processes.
Such violations can pose health hazards for consumers and hinder pharma companies' operations during inspections. Even the growth of booming segments like that of nutraceuticals can be offset by such violations, as industry bodies are particular about approving nutraceutical manufacturing for plants that can ensure no cross-contamination.
Besides improving the regulatory process, the government plans to focus more on upgrading micro, small, and medium enterprises. According to Raghuvanshi, 36% of the total MSMEs had to shut down temporarily, and around 10% had to permanently exit due to violations detected at their manufacturing units on risk-based audits.
For MSMEs, Raghuvanshi highlighted that discrepancies in process validation, documentation and inadequacy in quality controls are some of the key issues seen at such companies. "You should come to a culture where, without quality, you should not manufacture," he added.
"Most large firms have completed the upgrading process. We want to help the medium and small industries upgrade now," Arunish Chawla, secretary, Department of Pharmaceuticals, Government of India, told NDTV Profit. According to him, the government has taken several initiatives, such as introducing production-linked incentives and hiring consultants, to identify the gaps in manufacturing practices.
Skill training will be another area of focus for the government. "We have already started MTech courses in biotechnology and medical devices," Chawla said.
"We've also identified gaps in healthcare centres where there is a shortage of efficient technicians and professionals, for which we have a scheme for capacity building for the sector," he said. "In the next two to three years, you will see many certificate courses to remove this skill gap."
