Health ministry bans FDCs every few years. Ask how they enter the market in the first place

The medical rationale behind fixed-dose combination drugs soon gave into commercial interests that cared little for the health of patients. Government's only response has been to keep issuing ban orders since 1983.

Representational image | Flickr

A little more than two weeks ago, on 12 August, the Ministry of Health & Family Welfare announced a ban on 156 fixed-dose combinations, or FDCs in India, on the grounds that these drugs lack therapeutic justification, may pose risks to patients, and are clinically “irrational”. This latest ban is part of a seemingly never-ending saga that began on 23 July 1983, when the first such order was issued under Section 26A of the Drugs & Cosmetics Act, 1940.

In this game of “whack-a-mole”, the health ministry repeatedly invokes its power to ban FDCs every few years without addressing how these “irrational” combinations enter the market in the first place. The bans inevitably get caught in litigation, where judges further muddy the issue with poorly reasoned judgments.

A bit of history explains the true nature of the FDC problem. Originally, FDCs were created to improve patient compliance by combining two or more existing drugs for diseases requiring multiple medications, such as tuberculosis or AIDS. The rationale was that a single pill combining necessary drugs would simplify treatment for patients.

However, this medical rationale soon gave into commercial interests that cared little for the health of patients. Many companies began creating FDCs to circumvent the Drug Price Control Order (DPCO) by combining a price-controlled drug with one that was not, thereby evading the dragnet of the DPCO.

Another commercial motive driving the creation of FDCs was the need for pharmaceutical companies to differentiate products from competitors in a crowded market. If ten pharmaceutical companies sell the same antibiotic, the price will necessarily nosedive. By combining drugs, companies could market a “new” product and justify higher prices, even when no valid medical reason existed for the combination.

But mixing drugs is not like mixing food. Two drugs that are individually safe can interact adversely with each other when combined. This is why it is important for FDCs to be tested rigorously before being approved for sale.

Tackling the problem

In 1978, the growing scourge of FDCs in India was officially acknowledged in a government report. The government responded with two key measures. The first was to amend the Drugs & Cosmetics Act in 1982 to insert Section 26A, granting the Ministry of Health the power to prohibit drugs lacking adequate therapeutic justification. The second measure was to introduce a requirement in 1988 for clinical trials to test safety and efficacy of all drugs, including FDCs, before marketing approval.

On paper, these measures should have resolved the issue, but state drug controllers simply ignored the law. Thousands of unapproved FDCs continued to flood the Indian market, as documented by academics from India and abroad. A 2023 study published in the Journal of Pharmaceutical Policy & Practice reported that 239 unapproved FDCs containing antibiotics were being sold in the Indian market, which could have serious implications for rising antimicrobial resistance in India.

The opaque approval process for FDCs makes it difficult to assign blame, but the prevailing theory points to state drug controllers. According to the law, state drug controllers can issue manufacturing licences only for drugs whose safety and efficacy has been assessed and approved by the Drug Controller General of India (DCGI), who heads the national drug regulator, the Central Drugs Standard Control Organisation (CDSCO). However, many state drug controllers are ignoring this requirement by issuing licences for FDCs that are not approved by the DCGI.

A decade ago, the Central Bureau of Investigation launched an inquiry into how the drug controller in the union territory of Puducherry approved FDCs for five pharmaceutical companies. The CBI cannot take similar action in the states since it has no jurisdiction. The central drug inspectors, however, can initiate criminal action against pharmaceutical companies selling unapproved FDCs, but for unknown reasons, they have refrained from doing so. Instead, the ministry prefers issuing bans under Section 26A, which predictably become entangled in endless litigation.

A more effective solution would be to introduce greater transparency in the approval process. Requiring state drug controllers to publish the names of those granting manufacturing licences in a central register, along with an undertaking that they have confirmed prior marketing approval from the DCGI, could help deter the approval of unvetted FDCs. Regrettably, transparency has never been a priority for drug regulators in India, and therefore we continue to play this whack-a-mole game of banning FDC to create the veneer of accountability toward public health.

The writers are co-authors of The Truth Pill: The Myth of Drug Regulation in India (2022). They tweet @d_s_thakur and @Preddy85. Views are personal.

(Edited by Prashant)