Pharma companies listed the issues and challenges that plague the development of the sector in India even as Union Minister of Health & Family Welfare and Chemical and Fertilizers, Mansukh Mandaviya, hard pitched for India and Gujarat as investment destinations at the two-day summit held at Pandit Deendayal Energy University in Gandhinagar Saturday.
While noting that we could take pride in being the “pharmacy of the world”, Cadila Healthcare MD Sharvil Patel cautioned it posed a “significant challenge and risk to the success of the future” due to the sector’s dependency on China as revealed by the pandemic. “Overall, depletion of API, intermediate or biological substance, anything to do with drug substance, we become completely vulnerable to China and that needs to change. While a lot has been done by the government in terms of bringing better policies, I believe a lot more needs to be done fundamentally if we want to win this race against China,” Patel said.
Although he expressed confidence India would always do well when it comes to formulations, he emphasised the need to work on critical intermediate drug substances that are key to making any formulations. “There are inherent vulnerabilities. Today, we (Cadila Healthcare) carry six months of inventory so as to not face any disruptions. That is the kind of risk we have to take to ensure that supply doesn’t run out,” he said during a session on boosting bulk drug production through production linked incentive (PLI) scheme and reducing India’s import dependence in active pharmaceutical ingredients and medical devices.
He reminded that India would require “access to capital” and more improvement on the policy front so as to enable “large investments” in order to compete with China. “We may still win the small molecule race but we have lost the fermentation race, we have lost the biologics race. Today, to get a biotech product through in India, it takes 41 permissions. Can you imagine the time required to do so? At one point, clinical research became a challenge in India. Today, I do my work in the US. It is not just the regulatory issue, it is the whole ecosystem,” said Patel.
Industry leaders also cited snags in environmental clearances faced by many pharma units. Pressing on the need for faster environmental clearance, Patel said the problem was in clubbing together all industries — pesticides, dyes, intermediates and chemicals.
“I think linking the API industries with chemical industries has been a big problem for us in the state. The whole industry is looked at one way, whereas the API industry definitely has the capability to be less polluting, have zero discharge possibility and adopt green chemistry. We have not been able to set up large projects for the sheer reason of environment clearance. At Zydus, for four years we were sitting on land, which was not cleared because of environmental clearances” he said.