It’s been 36 years since the Justice Lentin Commission probed the death of 14 people at Mumbai’s JJ Hospital. The deaths were linked to DEG or diethylene glycol, a toxic contaminant that should not have been in the medicine.
But history seems to be repeating itself, only this time, in a different geography – as 66 young lives are lost in Gambia, possibly from the presence of DEG in four cough syrups that were sent from India’s Maiden Pharmaceuticals. A medical product alert on these syrups had been sounded by no less than the Chief of the World Health Organization, following which India’s health authorities also stepped up investigation.
The house is divided on whether the onus of this tragic, but completely avoidable incident, is to be placed entirely with the pharmaceutical company or the drug regulatory system, that let the “contaminated” product go forth into the market.
‘Zero tolerance’ needed
While some industry-watchers are calling for an overhaul of the drug regulatory system, several voices from within the system are emphatic that errant drugmakers can be caught with the existing resources. The need is for an unambiguos message of zero-tolerance to deviations from the rules that are already in place.
To send such a message, the regulatory authority — the office of Drugs Controller General of India (DCGI) — must take quick effective decisions and act on it, says a regulatory expert. In fact, some call for greater autonomy for the CDSCO (Central Drugs Standard Control Organisation) and the DCGI, so it can be more nimble to keep pace with the ever evolving and dynamic pharmaceutical sector.
Former Commissioner with Maharashtra’s Food and Drug Administration, Mahesh Zagade, is unsparing of lapses in the system. “In 1986, 14 people died. This was looked into by the Lentin Commission. There is no reason why in the 21 st Century, people die from use of the same chemical. The regulatory system is completely broken,” he said. Zagade headed the State authority at the time of Johnson and Johnson’s recall of faulty hip-implants. Acting on a patient complaint, he had escalated the issue by calling for compensation of Indian patients along similar lines as compensation given in United States.
Presently, as investigations are underway into the causal link between the paediatric syrups and the tragic deaths in Gambia, Zagade says, the tragedy would not have happened if the company had adhered to basic standards laid out by law. “We don’t learn lessons, and people will forget,” he says, adding however, that it’s not difficult to implement existing laws with the resources at hand.
The Central authority needs to direct States to ensure that the raw materials used are tested for purity, he says. Countering the view that errant companies fly below the radar by exploiting the dual nature of the regulatory system (since health is a State subject) – Zagade says, there is no ambiguity. The State gives manufacturing licences and inspects plants, etc., in line with central laws. The central authority is the overall supervisory body.
Unfortunately, he says, the system reacts only when there is a death. However, there are adverse drug reactions as well that may not result in death. They affect organs, lungs, eyes etc - but may not get adequately reported, he says, pointing to flaws in the system. There will be companies that will not comply, he says, calling for more regulatory teeth and accountability.
Zagade is emphatic that existing resources can be effective in ensuring that companies adhere to law. However, he adds, to govern a ₹3,00,000 crore pharmaceutical industry, investments should be made in training more personnel and strengthening laboratories across the country.
Agreeing with Zagade’s view, another regulatory representative (unwilling to be named) adds that existing labs need to be upgraded. And with anywhere between 6,000 to 10,000 manufacturing units in the country, the Centre needs to implement current Good Manufacturing Practices (cGMP) norms, he says, adding that too much was at risk, if left just to the industry.
The expert further suggests that the central regulator be given greater autonomy to function, citing examples of Brazil and Ghana. He also stressed the need for the central drug regulator to be a technical person.
With all the criticism that comes it’s way, S Srinivasan with the All India Drug Action Network says of the drug regulator, that they have to be seen to be just, besides having both integrity and predictability.
But against the backdrop of the Gambia tragedy, it may be necessary to revisit Justice Lentin’s report and views on the regulatory system. He makes a case for a strong regulatory authority that stands up to pressure and ensures that the law is adhered to, without fear or favour. A worthy guiding principle to strengthen the drug regulatory system and prevent the next medicine-linked tragedy from happening.