A new law that mirrors the old

The Union Health Ministry recently published a new draft bill to replace the Antiquated Drugs and Cosmetics Act, 1940. While we salute the Ministry for recognizing the need for a new law, there is much to disagree with the new bill. Initially, though the ministry has described this as being in line with the government’s move to review the obsolete pre-independence law, much of it is a copy of the old law. There is nothing new in this bill regarding drug regulation. And the bill does little to address the burning issues that have arisen over the past decade since the Ranbaxy scandal.

regulatory principle

The original Act was enacted when the Indian pharmaceutical industry was in its infancy. At that time, the guiding principle of this law was based on testing of manufactured drugs purchased from the open market by drug inspectors. If a drug fails a quality test, the manufacturer could be jailed. This was not the most efficient system of regulation as it depended entirely on luck or luck – only if a drug inspector chose a certain drug on a certain day and it failed the test would the manufacturer face legal action. . Much of the world has shifted to a more stringent system of regulation centered around compliance of manufacturing units with Good Manufacturing Practices (GMP). In theory, a drug manufactured in compliance with GMP is subject to so much scrutiny that it is unlikely that it will fail a quality test once it is on the market.

In 1988, India incorporated a system of GMP through rules made by the government instead of Parliament. But even then, the government did not make GMP the focus of its regulatory strategy. In the US, the regulator’s focus is on ensuring that manufacturing units are GMP compliant. US law recognizes that any drug manufactured in a facility that fails to comply with GMP is ‘adulterated’. Given this focus on GMP compliance, US law mandates the publication of reports of inspections conducted by its drug inspectors. On the other hand, there is no such criminal penalty in Indian law for pharmaceutical companies failing to comply with the GMP. At most, licenses can be revoked, but since inspection reports are never published, citizens have no idea whether drug inspectors are conducting GMP compliance-related inspections. There is sufficient evidence to suggest such inspections should not be carried out. The Bill does nothing to change this system. In fact, it doesn’t even mention the phrase GMP once.

question of federalism

One issue that has come up in every review of the drug regulatory system since 1947 is the uneven enforcement of the Drugs and Cosmetics Act across India. This is because, unlike the US, which has a single federal agency to enforce drug regulation across the country, India has 37 agencies for the same task: Central Drugs Standard Control Organization (CDSCO) with one in each state and union territory. Which is under the control of Union Health Ministry. State drug controllers are expected to license drug manufacturing and also take enforcement actions such as sampling, testing and prosecution for substandard drugs. The role of the CDSCO is limited to regulating imports and deciding whether new drugs have sufficient clinical evidence before they can be sold. Over the years, CDSCO has also begun taking samples to test and prosecute errant manufacturers. In addition, the health ministry is in charge of laying down rules and regulations and banning drugs that do not have clinical evidence.

One problem with this arrangement is that states like Himachal Pradesh, where a large amount of pharmaceutical manufacturing occurs due to tax holidays, do poorly in enforcing the Drugs and Cosmetics Act. This is not only because of the poor capacity of the state; Fear of scuttling investment by the pharmaceutical industry played a key role in the state’s decision not to implement the law. Since India is a single market, medicines manufactured in Himachal Pradesh are sold all over the country and even states with relatively more competent drug regulators such as Tamil Nadu, Karnataka and Gujarat are doing nothing to stop the influx of these substandard drugs. can. In Himachal Pradesh only the drug controller can revoke the manufacturing license of facilities located in that state. This is why the Mashelkar Committee recommended in 2003 to centralize drug licensing with a central regulator. The present Bill is silent on this issue. And since the ministry never issued a white paper explaining its position, we don’t know why the issue was never addressed.

democratization regulation

Drug regulation by its very nature vests vast discretionary powers for unelected bureaucrats to make decisions such as approving a new drug or a new manufacturing facility, both of which can have a huge impact on public health and the profits of the pharmaceutical industry. These decisions are often based on scientific data, observations, reports, etc. In such circumstances, transparency is the only way to ensure the accountability of the bureaucracy. As citizens, we should not need to run after the regulator begging for information under the Right to Information Act, 2005. Rather, the law should be written to guarantee proactive disclosure of all important documents related to regulatory decisions. If a new drug is being approved, the regulator should be required to disclose all data, including clinical trial data. Whenever a drug is tested in a government laboratory, the test report should be published on a publicly accessible database. Each inspection for GMP compliance must end with an inspection report accessible to the general public. This is the only way to ensure accountability and build public confidence in the regulator. The new law is silent on this important issue of transparency as it has been largely structured on the basis of the original colonial-era law. The government should consider rewriting this law in a way that guarantees transparency by design.

Modern regulation gives unelected bureaucrats and technocrats an incredible amount of power. From the point of view of efficiency, such delegation is needed, but from the point of view of accountability, it leads to a democratic deficit. This is why a modern regulatory system must be designed in a way that guarantees citizens the right to participate in decision-making. Making information available to citizens is the first step in this process. The next step is to create legal avenues, such as public hearings or civil litigations, that enable citizens to participate in the regulatory process and file their objections. For example, every drug approval process must be accompanied by a public hearing to allow doctors and ordinary citizens to question regulators and explain their rationale for approving a new drug. The proposed law does not make room for public participation.

Since the current reform process is still in its early days, no one will blame the health minister for scrapping this draft bill and appointing a new committee of outside experts to draft a bill, which would be the first for India’s independence. Celebrating 75th year reflects the democratic character of India.

Dinesh Thakur was the whistleblower in the Ranbaxy case; Prashant Reddy T. is an Advocate.