The colonial Drugs and Cosmetics Act, 1940 is finally on its way out as the draft of its replacement, Drugs, Medical Devices and Cosmetics Bill, 2022, was published by the Ministry of Health and Family Welfare (MoHFW) after a longstanding demand for new legislation to regulate drugs. The new Bill, however, falls short on several counts.
The drafters have missed an opportunity to modernise the regulatory structure for drugs by maintaining a status quo. The old regulation has already proved ineffective in ensuring the quality and safety of drugs marketed in India. Instead of rethinking the existing regulatory architecture, the draft Bill, rather unimaginately, merely brings under its umbrella a multiverse of provisions from secondary legislations.
The Bill does nothing to address the persisting fundamental problem of a fragmented regulatory architecture. Unlike other modern regulatory models such as the Food Safety and Standards Authority of India (FSSAI), drug regulation is disorganised coming as it is under several regulators: the Central Drugs Standard Control Organisation (CDSCO) — a non-statutory authority housed under the Directorate General of Health Services, MoHFW — and three dozen state drug regulators housed under their respective state health departments.
The CDSCO lacks financial and functional autonomy and does not act as an oversight authority for state drug regulators, which largely function independently with no co-ordination between them or with the Centre. This lack of hierarchy between the CDSCO and state drug regulators, leads to a porous regulatory framework with several lacunae.
In the absence of a clear line of command, the responsibility of all becomes the responsibility of none, and nobody can be held accountable for the effective implementation of the law. The failure on the part of five different state drug regulators in appropriately testing and withdrawing tainted batches of remdesivir, for example, led to several adverse events during the second wave of Covid-19. Lack of centralised oversight and accountability mechanisms has severe implications on the health of patients.
As far as the division of regulatory functions is concerned, while the quality standards for drugs are set centrally by the Indian Pharmacopoeia Commission (IPC), the power to issue manufacturing licenses for drugs continues to be vested with state regulators under the proposed Bill. In effect, the new Bill neglects several expert committee recommendations to vest this power in the CDSCO, and instead grants this power substantively to state drug regulators under the Act. Currently, states exercise this as a delegatory power under the Rules.
As a result of this flawed division, drugs manufactured and licensed in different states do not go through a uniform level of scrutiny, defeating the very purpose of centralised standardisation. Lack of uniformity also leads to inequitable access to safe drugs. Since India has a common pharmaceutical market, drugs manufactured in one state can be, and are, marketed in the other regardless of uniformity in their quality. Further, these licences can only be suspended or cancelled by the licence-issuing state regulator, which leaves other state drug regulators dependent on it to take action in cases of non-compliance. For instance, an adulterated cough syrup manufactured in Himachal Pradesh resulted in the death of 12 children in Jammu.
While the manufacturer allegedly manufactured substandard drugs multiple times in the past, the lack of timely intervention by the state drug regulator in Himachal Pradesh had severe implications in other states. While state drug regulators have the power to launch prosecutions against drug manufacturers from any state, these have been left uncoordinated and negligent under the existing Act. There is poor communication, lack of documentation, and an unwillingness to cooperate with drug regulators in other states. The process is now so adversarial and disjointed that FIRs have been filed by state drug officials against their counterparts in other states who refuse to hand over documents. Fundamentally, these issues are a consequence of the lack of a central oversight body, which has the power to facilitate coordination across disparate state drug regulators.
Every serious analysis of India’s drug regime attracts the same set of criticisms: fragmented regulatory structure, poor enforcement, and accountability mechanisms that are not effective. These issues demand a modern regulatory approach; this Bill is a half-measure. The ministry should start afresh and publish an ambitious white paper that addresses the current issues plaguing the existing regulators, the regulations they enforce, and the prosecutions they sanction and bring. It should be presented before a parliamentary committee, subjected to scrutiny and debate, and followed by a draft Bill prepared in consultation with the relevant stakeholders.
Real reform is undoubtedly difficult. It will require the willingness to legislate in the face of opposition from a powerful industry and a reluctance on the part of existing administrations to change. But it will also allow ministers and civil servants to demonstrate that they accord top-most priority to the health of their citizens. They have here an opportunity to inspire confidence in the regulator and the regulatory approach.
(Shrivastava is Senior Resident Fellow and Sahu is Research Associate, both at Vidhi Centre for Legal Policy)