Last week the top Indian drug regulator sent out a letter to all State Drug regulators on how to conduct inspections of pharmaceutical production plants. It was revealing for what it said and also that it was sent at all.
India’s drug regulator, the Central Drugs Standard Control Organization, has come under a lot of criticism in the recent past, both from foreign experts, and from India’s own government. CDSCO has been accused of corruption and collusion with local companies as well as failing to oversee drug quality domestically and for export.
Part of the problem is that it is handicapped by colonial laws drafted by the British, which give it limited legal responsibility. Add chronic underfunding and politicized leadership of CDSCO which rewards the commercial success of Indian drug sales rather than protection of patients, and it is understandable why India’s companies have run afoul of western regulators.
Dr GN Singh, the Drugs Controller General of CDSCO was the author of the letter sent to State Regulators, which can be found here.
What is most startling is the tacit acknowledgement that existing regulatory practices were just a joke. If the inspections they did in the past, which apparently this is aimed to correct, never had a plan, a process and a method for determining outcome, what exactly were the CDSCO inspectors doing on these supposed inspections?
Second, why is there a time limit on future inspections? Shouldn’t we want the inspectors on the ground to make that determination of how long they think they need to complete the inspection to ensure product safety?
Third, what kind of delays were encountered in the past post inspection for preparation of inspection reports? Clearly, this is a time where a lot of horse trading goes on between the inspector and the manufacturer. It would be interesting to know what metrics they have on this timeframe. The US regulator for example, publishes an annual report of metrics on the inspections it conducts which provides an insight into the problems it encounters most, their resolution and other administrative data such as frequency of such inspections. No such data or transparency has ever been shown by the CDSCO.
But the biggest problem with the current approach is that it uses the incomplete, antiquated and hole-riddled Schedule M as the basis of their assessment of risk, not ICH. Given how inadequate Schedule M is, it seems unlikely that inspections will improve given Dr Singh’s letter.