Fixing Accountability for Preventable Tragedies in The Gambia: Lessons for Indian Regulators
On October 12, Haryana’s Minister of Health, Anil Vij said that the Haryana state government had decided to completely halt all manufacturing activities of Maiden Pharmaceutical Limited, a company based in Sonepat, Haryana, for manufacturing and testing drugs in contravention of the rules. The Department of Food and Drugs Administration (‘FDA’), Haryana, would have issued a notice under Rule 85(2) of the Drugs and Cosmetics Rules, 1945 to the company asking why the company’s manufacturing license should not be suspended or revoked due to violations found during inspection ordered by the Central Drugs Standards Control Organization (âCDSCOâ), the national authority regulation of cosmetics, pharmaceuticals and medical devices.
The state government’s sweeping move against the company follows the World Health Organization (‘WHO’) emission a medical product alert for four “contaminated” cold and cough syrups manufactured by Maiden Pharma Ltd. October 5. The company is licensed by the Haryana Drugs Controller.
The consumption of these drugs is linked to the death of more than 66 children in The Gambia, and was appointed as “one of the worst incidents of its kind involving drugs from India”.
According to the WHO, laboratory analysis of samples of each of the four products confirms that they contain ‘unacceptable amounts diethylene glycol and ethylene glycol as contaminants. Diethylene glycol and ethylene glycol are toxic to humans when consumed above certain levels and can be fatal.
In a bizarre assertion, a press note, released by the Press Information Bureau on October 6th, revealed that the Haryana Drugs Controller has granted licenses to Maiden Pharmaceutical, solely for the export of these four drugs only to The Gambia, and not for manufacture and sale in India. “It is usual practice for the importing country to test these imported products on quality parameters and ensure the quality of the products before the importing country decides to release these products for use in the country.asserted the Union government, in an attempt to absolve any responsibility on the part of the state regulator.
Moreover, the emphasis placed by the Union Government on the fact that the license was granted to the company only to export the drugs in question, and not for use in India, is shocking, as it suggests that compliance standards, as far as licensing is concerned, are not rigorous in the case of exports, or that the lives of persons abroad who are likely to consume such drugs, the distribution or sale of which is prohibited in India, doesn’t matter.
The Union Government has further disclosed that according to interim results received by the WHO, of the 23 samples of the referenced products that were tested, four samples contain diethylene glycol/ethylene glycol. He was also informed by the WHO that the certificate of analysis would be made available to the WHO in the near future, and that the WHO would share it with the Indian regulator. The exact causal relationship of death has not yet been provided by WHO to CDSCO, the Union government said.
The drug samples have been sent for testing at a regional drug testing laboratory by CDSCO and the results of these tests will guide further action, the Union government added.
According reportsThe Union Department of Health on Wednesday set up a four-member technical expert committee to review and analyze reports of adverse events and advise the government on how to proceed.
Srinivasan, from the non-profit organization Low Cost Standard Therapeutics, and co-organizer of the All India Drug Action Network, an independent network of several non-governmental organizations, explaining the role of national drug regulatory authorities in granting authorization for the manufacture and distribution of medicinal products, says The booklet: “The role of the regulatory authority, with respect to the manufacturing license, is to approve a particular manufacturing process submitted by the manufacturer. The manufacturer must stick to the manufacturing process approved by the Drug Controller.â
According to Srinivasan, when applying for a manufacturing license, detailed information should be provided about the formulation of a particular drug in a master formula card. “No regulatory authority, unless negligent, would have given approval for the license to manufacture a syrup involving the use of Diethylene glycol or ethylene glycol â as they are known to be toxic. Once the license is granted, a regulator has no real-time control over what the manufacturer manufactures or exports. The manufacturer has to follow the rules as per the conditions stated in the license i.e. it is the responsibility of the manufacturer to produce quality drugs once the approval is given. Of course, the regulatory body using the commercial information available to it may take samples from the premises of the manufacturer and/or retail outlets.” he added.
Further, Srinivasan explained as follows: “In the manufacture of any drug, where there may be ten or more elements, tests must be carried out on each of them before formulating them into a syrup. or a tablet. Therefore, the manufacturer should have carried out preliminary tests on the solvent. Â»
In this case, Srinivasan felt that the manufacturer could have used a non-pharmaceutical grade solvent for the formulation of the syrups – the non-pharmaceutical grade solvent may have had unacceptable levels of diethylene/ethylene glycol. In any case, the solvent should have been routinely tested before use in syrup, and the resulting test report would have highlighted this fact, but the manufacturer chose to ignore it, or the tests in itself could have accepted the solvent when it should not have been, he added.
As the next step is the role of the regulatory authority, especially now after the deaths, Srinivasan said that firstly, an investigation must be carried out into the matter, which means in this case the suspect solvent must be identified, and the premises of the solvent manufacturer are visited and their records studied. He stressed that the regulator must identify all other syrup makers who received the suspect solvent, recall their products and take action against them.
Second, Srinivasan said, if the manufacturer is found guilty of negligence, the law must be followed in prescribing the penalty. Third, consider whether the solvent maker has the appropriate manufacturing licenses and other permits, he added.
While the primary responsibility lies with the manufacturer to ensure compliance with standards and rules, he said, regulatory oversight should have sent alarm bells ringing at the medicines regulator – especially since the maker of the syrups contaminated had a questionable record of manufacturing, blacklisting, and warnings.
Section 27(a) of the Drugs and Cosmetics Act, 1940 penalizes the sale or manufacture of drugs considered “falsified” under the law, and provides for a ten-year prison sentence, which can be extended to life imprisonment, and a fine of at least ten lakh rupees or three times the value of narcotics confiscated.
However, although CDSCO’s investigation is still ongoing, it is reported that Maiden Pharma is known to be a repeat offender in India. In 2011, the government of Bihar blacklisted company for the sale of substandard medical products. In 2014, the company was among the 39 questionable companies blacklisted by Vietnam.
In 2017, in a case filed by the Kerala Drug Controller, the Magistrate, First Class Court, Neyyattinkara, Kerala imposed a good of Rs. 1,000 on the unit. In 2018, in the case of Indian Union v M/s Maiden Pharmaceuticals Pvt. ltd., the manufacturer was for follow-up under Section 27(d) of the Act for the manufacture or sale of drugs contrary to the provisions of the Act.
The CDSCO has been criticized for allowing Maiden Pharma exports despite the manufacturing unit’s poor track record. He received a certificate of pharmaceutical product, guaranteeing foreign buyers of the manufacturer’s compliance with WHO standards. Good Manufacturing Practices. “Given the wonderful track record of this company, does this not raise the question on what basis is CDSCO issuing this document??”, public health activist Dinesh Thakur noticed on Twitter.
Moreover, it is also reported that the FDA’s State Department, responsible for conducting inspections and issuing licenses for the manufacture of drugs, is severely understaffed. The Haryana Drug Control Department is reportedly operating at a capacity of 35.84% of the workforce sanctionedone wonders whether or not âroutine and mandatoryâ inspections are carried out.
Thus, criminal negligence, punishable under Section 304A of the Indian Penal Code, is suspected both from the pharmaceutical company and from state and national regulatory authorities.
Apart from the recent deaths in The Gambia, India is also said to be notorious for manufacturing and selling substandard drugs in the country. For example, as recently as February 2020, at least nine children died in Udhampur, Jammu and Kashmir due to the presence of diethylene glycol in cough syrups. A roadmap is yet to submit in the case. In a report of The Tribunean analysis of CDSCO’s monthly substandard drug alerts shows that of the 10,062 samples taken, 306 were found to be substandard.
In a recent article by The economic period, Thakur and lawyer Prashant Reddy T highlight the need for a binding drug recall mechanism in India. They point out that although the CDSCO has published callback instructionstheir non-binding nature is problematic in a country like India, with a highly fragmented regulatory structure in which each state and union territory has its own medicines regulator, in addition to the central CDSCO.