If the government is looking for a quick response to the tragedy in The Gambia, it should begin with tackling this messy record-keeping. It would be amazed at the transformative effect such a step could have on drug quality in our supply chain, and consequently, our global reputation
The deaths of 66 children in The Gambia due to an adulterated cough syrup manufactured in India has finally focussed attention on the country’s dysfunctional drug regulatory system. The company that allegedly manufactured the drug has a sordid history of being hauled up by different regulators in India and other countries. Yet, it appears that the company never lost its manufacturing licence, issued by the state drug controller with jurisdiction over manufacturing facilities.
Much will be written on a number of factors that led to these deaths, including India’s fragmented drug regulatory framework, the consistent failure of Indian companies to follow Good Manufacturing Practices and an understaffed regulatory system (HT Photo)
Much will be written on a number of factors that led to these deaths, including India’s fragmented drug regulatory framework, the consistent failure of Indian companies to follow Good Manufacturing Practices and an understaffed regulatory system. But there is a deeper question: Why do countries such as The Gambia purchase drugs from a company with a poor track record? Unfortunately, this may be because India does not have a consolidated public database that records the transgressions of each company licensed under the Drugs and Cosmetics Act.
We use the word “consolidated” because India has 38 drug regulators today — one for each state and Union Territory, plus the national regulator, Central Drug Standard Control Organisation. Each controller has its own network of laboratories to test drugs drawn from the market under its jurisdiction by its drug inspectors. Between the Union and the states, India has 37 drug-testing laboratories, yet laboratories of only three states — Gujarat, Maharashtra and Kerala — make their results available in a consolidated database (https://xlnindia.gov.in).
Sadly, even this website doesn’t show the entire test report. A consolidated database where potential purchasers can establish the track record of pharmaceutical companies would improve the quality of information available to purchasers dramatically.
Test reports are only one part of the puzzle. Other records that can make a difference are inspection reports and prosecution records instituted by drug inspectors across the country. Since each state has its own drug controllers who conduct their own inspections and file their own prosecutions, they maintain their own records, which are difficult to access. For example, while researching for our book, The Truth Pill, we filed requests for information under the Right to Information (RTI) Act with multiple states asking for a record of their prosecutions of erring pharmaceutical companies. In response, some states transferred our request to every district in their state and each district then provided the information in varying formats. Some districts refused to share any information and asked us to visit their office. Some states refused to share information on the grounds that it was voluminous. Some states that cooperated sent us bulky photocopies of handwritten registers — in the age of the internet and digital record-keeping. Imagine, if there existed a consolidated, publicly accessible digital database of all inspection reports, prosecutions and resulting court judgments that could be accessed by customers who wanted to check the track record of pharmaceutical companies. It would automatically eliminate bad actors.
The most controversial records, however, are those that pertain to drug approvals. These record the subjective satisfaction of the Drug Controller General of India (DCGI) on why a particular new drug is being approved for sale in India. In 2012, the scathing 59th report of the Parliamentary Standing Committee on Health noted that multiple new drug approval files summoned for review were missing from DCGI’s office. In files produced before the committee, a few Members of Parliament discovered serious discrepancies. Subsequently, the ministry promised a thorough probe but delegated the task of instituting the probe to DCGI itself. The controller did institute an inquiry committee under Tribhuvan Mohan Mohapatra, which submitted its report in 2013 but was never sent to the ministry or parliamentary committee. When we asked for a copy in 2018 under the RTI Act, we were told the report was “untraceable”. After we knocked on the doors of the Central Information Commission in 2020, DCGI sent us an unsigned copy of the report sans annexures.
One of the main observations in the Mohapatra Committee report, apart from accusations of impropriety against former DCGIs, was that record-keeping was abysmal as the committee was unable to even access all the files required for its oversight exercise. After we approached the Delhi high court over the missing annexures, the ministry filed a vague affidavit about the digitisation of its records. However, as we pointed out to the high court and, in a separate petition, to the health ministry, even digitised records need to be made publicly visible on the internet.
If the government is looking for a quick response to the tragedy in The Gambia, it should begin with tackling this messy record-keeping. It would be amazed at the transformative effect such a step could have on drug quality in our supply chain, and consequently, our global reputation.
Dinesh S Thakur and Prashant Reddy are co-authors of The Truth Pill:The Myth of Drug Regulation in India The views expressed are personal
