India’s drug regulation needs an overhaul

Centre must reform CDL, plug drug-testing gaps to prevent incidents like the Ballari maternal deaths.

Substandard drugs are back in the news with the four maternal deaths in the Ballari district of Karnataka. Contaminated Ringer’s lactate solution administered to mothers who had just delivered babies has been identified as the cause of the deaths.

These deaths extend a long list of tragedies that involve contaminated drugs manufactured by the Indian pharmaceutical industry. Since 2020, these drugs have been identified as reasons for the death of 12 children in Jammu, 70 children in Gambia, 18 children in Uzbekistan, 12 children in Cameroon, three children in Delhi, five people in Chandigarh, and four children in Colombia. Additionally, treatment failures –
many of them fatal – caused by substandard drugs that lack the adequate active ingredient or that fail to dissolve are often difficult to identify and quantify because India lacks a reliable pharmacovigilance mechanism.

Unlike the above tragedies, the Ballari case is different – the quality control mechanisms within the state did identify the drug in question as substandard, in January of this year. From public records on the website of the Karnataka Drug Control Department, we know that a sample of Ringer’s lactate drawn by a drug inspector failed quality tests on January 8, leading to the Karnataka State Medical Supplies Corporation Limited which had purchased the drug blacklisting the manufacturer in March.

The only reason that the drug was released back into the market for use, as per the state’s Health Minister, is a certification by the Central Drugs Laboratory (CDL) in Kolkata that the drug was of standard quality. Under the Drugs & Cosmetics Act 1940, CDL which functions under the Union Ministry of Health is the appellate laboratory that can be approached by manufacturers who want to challenge the test results from the state laboratory. CDL’s report, then, is the final word.

The Karnataka Health Department has requested the Central Drugs Standard Control Organisation to initiate a probe into the supply of the substandard injection. Questions need to be asked – we say this because two earlier incidents involving CDL and the Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, have raised doubts about the laboratory’s functioning.

The first incident involves the deaths of five patients at PGIMER in 2022 which was blamed on a contaminated drug. The institute’s director, in statements to the media, blamed the deaths on the drug which he claimed tested as “very toxic”. Testing by the Regional Drug Testing Laboratory (RDTL) in Chandigarh revealed that the injection was contaminated with bacterial endotoxins. Six months later, in March 2023, the Union Minister of State for Health informed the Lok Sabha during question hour (Q. 4972) that when the manufacturer appealed for a second test at CDL, the drug miraculously cleared all the quality tests. CDL does not make publicly available its test reports or testing protocols and it is not possible for us to independently verify the Minister’s statement. Testing for bacterial endotoxins is a simple, straightforward process with a very low error rate. Given that five patients did die after being administered the batch in question, CDL’s clean chit, overriding the rather well-equipped RDTL, does not pass the smell test.

In the second instance, a pharmaceutical company was blacklisted by PGIMER because its drugs failed quality testing at RDTL. The drug in question was Tacrolimus, used in organ transplant patients. The pharmaceutical company subsequently informed PGIMER that it had received a clean chit from CDL where the drug was sent for testing and therefore, requested it be removed from the blacklist. However, a subsequent internal investigation by PGIMER revealed that the test reports were forged. In December 2023, the hospital management filed a complaint with the Chandigarh Police alleging forgery of CDL’s reports.

Lack of transparency

Both incidents raise serious questions about CDL’s functioning. CDL does not make publicly available in a centralised database basic information such as its test reports, testing protocols, and the names and qualifications of authorised personnel responsible for carrying out the tests. If the test reports are easily available, it would be possible for others, especially in the government, to easily verify the authenticity of reports submitted to them. Similarly, if testing protocols were made public, CDL would open itself up to the scrutiny of its peers, which is required for public institutions making scientific decisions that have far-reaching implications. Given the sheer power that CDL exercises as the ultimate “appellate” laboratory, such transparency is a basic necessity. However, CDL has been exceptionally hostile to the idea of transparency and has fought us till the Central Information Commission over routine requests for information that were readily provided by other central and state drug testing laboratories. Such brazen defiance of the RTI Act is, generally, a symptom of poor governance and gross unaccountability.

The second level of the problem involves the porous chain of custody by which samples are sent to CDL by states. Drug inspectors, court staff, postal authorities, and CDL staff are all involved in the process and there are too many points of potential failure where samples can be replaced. The entire process for authentication, involving wax and brass seals, was laid out in 1945. Final test reports are still communicated by snail mail. Lapses in the process, including the lack of proper storage during the transfer of samples to labs, and delays in testing beyond the expiry date can lead to acquittals in subsequent litigation.

Reforming CDL and the Drugs & Cosmetics Act 1940 is the responsibility of the Union Health Ministry. There is little that individual states like Karnataka can do, especially in cases like the Ballari deaths where both the manufacturer and CDL – the two key players – were located outside the jurisdiction of
the state government. It is high time states demanded from the Union Government steps to reform drug regulation in the country.

(The writers are co-authors of The Truth Pill: The Myth of Drug Regulation in India)