With New Drug Policy, India Has A Golden Opportunity To Grab On Apis

The coronavirus pandemic has highlighted the need for diversification in pharma manufacturing and raw material sourcing to reduce dependence on just one country – China. US Pharmacopeia, a US headquartered public standards-setting organisation for drugs and food worldwide, says the spotlight is now on India.

With a new bulk drug policy, India has a golden opportunity to grab the lost battle on APIs and raw material manufacturing. Dr K V Surendranath, VP of Global Sites for US Pharmacopeia, in an interview with CNBC-TV18 said when managing drug shortages during a health crisis the onus is on regulators to assess quality of drugs sourced. He highlighted instances that substandard versions of “potential” COVID treatments like HCQs are already making their way into the global supply chain, despite its efficacy being under question. Edited excerpts:

Q: How prepared is the world to handle drugs and raw material supply shock if China goes through another crisis?

Ans: This pandemic itself may go into several cycles, as the virus is moving from country to country and has become a global crisis. Disruptions would recur and the situation is not going to be normal anytime soon.

COVID-19 showed the world the unpreparedness of the pharma industry to tackle pandemics and natural calamities. Research in therapeutics, vaccines and critical drugs is challenging now.

There is a massive supply chain disruption and disruptions in manufacturing. Many countries will be forced to think about changes in procurement and emerging technologies like continuous manufacturing could enable expanding quick manufacturing at local levels.

Q3: India has approved a new bulk drug policy. How much time before India can actually make a difference in manufacturing and reduce dependence on China?

Ans: The policy is certainly welcome and over-dependence on certain countries could be dealt with. However, several other factors like how the government incentivises API manufacturing, infrastructure, venture capital and ease of doing business will be important.

India has capacity on certain APIs, especially small molecules to ramp up production. Major issue is the antibiotics where fermentation processes and bulk reactors are required and the whole world is dependent on China. That may be a challenge unless some policy assistance is provided.

Small molecules could be done in 6 months to 1 years, but antibiotics raw material could take a little longer as specific infrastructure is required.

Q: USFDA has changed its audit protocol during the crisis to no in-site audits. Multiple plants around the world have pending audits as they continue to supply drugs. Certain companies have been given fast track approval – like Cipla for its nasal spray and others like IPCA Labs has received relaxation on import alert as they are suppliers of HCQ. Is there a concern on the quality of medicines considering disruption of the audit cycle?

Ans: In crisis situations, regulators need to focus on strengthening supply chain which means the need to give accelerated approvals. Policy makers should encourage manufacturers to have back up plans, including production lines and quality control. Critical medicine manufacturers should put redundancies in place in event of acute disruption.

The supply chain disruption has created a shortage of drugs. The onus is on the regulatory agencies to establish strict quality testing of drugs when getting drugs from unapproved sources or sourcing it from sites and plants where they have had quality concerns.

USFDA is taking precautions that all drugs are tested for quality when they reach the US ports. In emergencies when audit and manufacturing approval norms are relaxed it is also on the pharma companies to prove the integrity of their manufacturing and systems, or else they can be blacklisted from future marketing authorisation in the US.

Regulators also need to change CGMP systems on vendor, manufacturing validation and audit protocols. This is important because a lot of substandard and mislabelled drugs can find a way into supply chains by intentional adulteration done by suppliers to achieve higher profits.

Q: Are you seeing instances of substandard in the last 3 months of pandemic? Have we seen the quantum of counterfeits and mislabelled drugs go up?

Ans: In normal scenarios, around 30 percent of medicines around the world, specially developing and under-developed world are counterfeit. In the current crisis, a few cases in the US, Brazil, Mexico have come to light where counterfeit drugs are making way. In a panic situation, people are trying to procure drugs approved by the government as potential COVID-19 treatments are seeing some shortage. Most of these potential COVID-19 drugs are only available on prescription.

And, since only COVID positive people can go to health centres, others are buying it over the internet. They are bound to get counterfeit drugs on the internet.

Q: While the governments around the world are approving HCQ, the medical fraternity is still questioning its safety protocols. From the US Pharmacopeia perspective, is this advisable to be used?

Ans: USP believes the efficacy of HCQ is not proved and is questionable for sure. The medical fraternity is right about the side effects and questionable protocols. I think we need to know what level of dosages are safe and what level of efficacy it has. It is essential that HCQ is administered in limited dosages under medical supervision at a time when there are no protocols available.

We may be in a better situation when more case studies emerge in a few months. We understand the Gates Foundation, among other organisations, is doing research on the drug and some evidence may be presented in the coming months.

Q: India has emerged as the key supplier of Hydroxychloroquine and is somewhere also defining India-US bilateral trade. How do you look at the HCQ supply chain and India’s position?​

Ans: Not only the USFDA but other regulators are also working with Indian government to arrange HCQ from India and formalise the supply chain. The US-India relations has become of paramount importance during this crisis and as after effects of COVID-19 will see disruptions continue, India-US bilateral trade will be important. India has a golden opportunity to diversify manufacturing and attract several countries to invest in India.

However, globally we need greater transparency and information sharing on supply chain mechanism. Enhanced global cooperation is required and Pharmacopoeia and governments from around the world need to share information. USP advocates increasing geographic diversity for ingredients & manufacturing.-CNBC 18