Who should staff the new regulator? A parliamentary standing committee on health and family welfare first raised concerns about the people staffing India’s drug regulator, the Central Drug Standard Control Organisation (CDSCO). It is run by a bureaucracy qualified mainly in pharmacy. Other drug regulators in developed countries are staffed with multi-disciplinary teams of professionals typically led by a doctor with experience in public health.
India is yet to move away from understanding drug regulation as purely a manufacturing issue to a public health one. Technically, the qualification criteria in the Drugs and Cosmetics Rules, 1945, for both entry level positions as drug inspectors and the top position of Drug Controller General of India (DCGI) allows for doctors to be appointed to these posts. However, that criterion is accompanied by a requirement to have 3 and 5 years of experience respectively in the manufacture or testing of drugs.
While doctors are employed by pharmaceutical companies, they are seldom involved in manufacture and laboratory testing of drugs, their role being in clinical research. This absurd qualification criterion continues despite a GoI expert committee agreeing with the parliamentary committee. At the state level, the situation is worse. In Telangana, the state drug controller has historically been an Indian Police Service (IPS) officer as the state views drug regulation as a ‘law and order’ issue. In Andhra Pradesh, an officer from the Indian Revenue Service (IRS) dedicated to collecting taxes was once appointed as the state drug controller.
The new Bill does nothing to correct this situation. Instead, it delegates the power to state governments and GoI to decide the qualification criteria for their respective drug control officers. This is unlike the existing law where GoI laid down the qualification criteria for drug inspectors and licensing authorities across the country. The ministry must consider providing for the qualification criteria in the text of the Bill and ensure that a modern regulator is staffed with specialists from pharmacology, medicine, chemistry, and the biology regulatory sciences.
Creating an independent regulator: The Bill does nothing to upgrade the archaic status of CDSCO. In the pre-1990s, regulators did not have an independent legal existence. They fell within GoI’s remit. This essentially meant:
*Regulators would be bound by all the cumbersome GoI rules ranging from recruitment to financial powers.
*They would not have any ‘rule-making’ powers. All requests to create or amend rules would be made to the secretary of the ministry, generally an IAS officer who may or may not have expertise on the topic.
*Regulators could be overruled by the ministry exercising oversight on certain issues. For example, the Drugs and Cosmetics Rules clearly provide for an appeal against the decision of drug controllers to the central or state government, thereby allowing the minister acting on the advice of a non-specialist bureaucrat to overrule specialists making regulatory decisions.
Post-liberalisation, a new regulatory model was put in place with the creation of regulators like the Securities and Exchange Board of India (Sebi), Telecom Regulatory Authority of India (Trai), etc. Each of these regulators were ‘independent,’ not in the sense of judicial independence, but in that they were created with their own corporate existence separate from GoI.
This meant that although they were still answerable to a ministry and an elected minister, they could create their own recruitment and financial rules, allowing them the flexibility to operate with less red tape and hire better talent laterally from the private sector. More significantly, they were also given a limited degree of rule-making power so that they could respond to situations on the ground more rapidly.
The new Bill misses the bus on this issue, despite a 2013 legislation that was never voted upon in Parliament actually having proposed this model for a new drug regulator. As of today, CDSCO is an attached office to the Directorate General of Health Service (DGHS), itself a department of the health ministry answerable to the secretary. Simply put, CDSCO and DCGI who heads it are far away from the centre of power.
GoI also has a ‘drug regulation section’ under a joint secretary in charge of the rule-making powers under the Drugs and Cosmetics Act, 1940. It has the power to ‘prohibit’ drugs despite not really having any role in drug approvals. That the health ministry wants to continue with this outdated structure reflects poorly on the committee responsible for drafting this new law.