US control not necessarily bad

Activists here are urging the government to put in place strict regulations to oversee Indian drug manufacturing

Recently, whistleblower Dinesh Thakur, a former Ranbaxy staffer, sued the health ministry, the Drugs Consultative Committee and the Central Drugs Standard Control Organisation, accusing them of failing drug safety rules.

But the biggest lacuna in the Indian regulatory set-up is its fragmented nature. With drugs being listed in the Concurrent list of the Constitution, both state and Centre can have authority to regulate this sector. But wherever state law clashes with the Centre’s, the latter is designed to prevail. In India therefore, each state has its own drug-licensing authority and all a drug maker needs is permission from one state to sell a particular recipe nationally. This essentially means... if drug safety process is diseased in one state, it could infect other states too. While admitting that Indian regulators are not as stringent as their US counterparts, a pharma veteran says prices of drugs could increase if Indian drug regulators seek to enforce FDA-like standards here.

But the Drug Controller General of India had issued a circular in August last year, asking pharma companies to upgrade staff skills by January 1, 2018. The DCGI had also issued a directive to distributors and retailers to procure medicines from only authorised channels and to quarantine spurious drugs and their sellers. “As the low skills sets outweigh the other factors in the economy, we cannot compromise on the skilling of our manpower,” said Ranjit Madan, CEO of Life Sciences Sector Skill Development Council in Mumbai, set up to train pharma workers.

While this realisation has dawned late in India, certain groups wonder if the time’s right for the setting up of a single drug regulator and licensing authority for the country. Because if India can have one single indirect tax, why can’t it report to one drug authority? Is the Prime Minister listening?