A court in Sonepat, Haryana, has convicted two directors of Maiden Pharmaceuticals in a case relating to exports of substandard ranitidine. In October last year, World Health Organisation had linked Maiden’s drugs to the death of 66 children in The Gambia. Sarthak Ray takes a look at Maiden case and India’s drug-quality regulation.
Why Maiden is in the news
A court in Sonepat, Haryana, last week convicted the drug-maker, along with its director NK Goyal and technical director MK Sharma, in a case involving export of substandard ranitidine, a drug used to relieve stomach acid related heartburn and reflux. Both Goyal and Sharma have been sentenced to two years and six months of rigorous imprisonment and fined Rs 1 lakh each, under the Drugs and Cosmetics Act (DCA) 1940.
In December 2013, the Indian consulate in Vietnam informed the Centre that Vietnam had blacklisted 46 Indian drug-makers for quality violations. Maiden was the fourth company on the list. In February 2014, the Drugs Controller General of India (DCGI) sought a probe by the Central Drugs Standard Control Organisation (CDSCO), based on the Vietnam list.
What the CDSCO probe found
The Drug Inspector at the CDSCO’s sub-zonal office in Baddi and the Drug Control Officer, Sonepat, visited Maiden’s premises in March 2014 and sent ranitidine samples to the Regional Drug Testing Laboratory (RDTL) in Chandigarh. The RDTL reported that the sample didn’t meet the quality standards prescibed by the DCA,based on the specifications of uniformity of weight and assay laid down by the British Pharmacopoeia 2013.
Maiden subsequently said that hadn’t sold the batch because it was aware of the quality concerns, but couldn’t destroy the drugs because of compliance with other laws. The Sonepat court said that the company didn’t adhere to the Drugs and Cosmetics Rule provisions on segregated storage of rejected products, with a likely intention to sell these. The sentence of the two directors has been suspended pending appeals before a higher court.
Repeat offences?
In October 2022, WHO flagged the contamination of four products made by Maiden; tested samples had “unacceptable amounts of diethylene glycol and ethylene glycol”. The toxic effects of the two contaminants include “acute kidney injury which may lead to death”. WHO also said “their use, especially in children,” could cause “serious injury or death”. Deaths of 66 children in The Gambia, where the unsafe products were first reported, have ben linked to Maiden’s products. However, the DCGI told WHO on December 13, 2022, that the samples it got tested were found to be “complying with specifications”.
Some media reports say Maiden might have also claimed WHO certification while WHO denies having granted this. Substandard drugs from its facilities have also been flagged by the Kerala and Gujarat authorities, in the extended licensing, laboratory and legal node database of the the Centre, a media report says.
Inadequacies of India’s drug regulation at the root?
Drug regulation in India, many experts argue, remains a complex maze. To a large extent, the guiding law is the Drugs and Cosmetics Act 194. Under the DCA 1940, the CDSCO officiates as the drug standards controller, with the DCGI heading the body. The CDSCO operates through its regional, zonal and sub-zonal offices. The various offices of the CDSCO carry out functions such as inspections, market surveillance and recall. The DCGI is advised by the Drug Technical Advisory Board and the Drug Consultative Committee. The states have their own Drug Regulatory Authorities, with some regulatory role.
The fragmented regulatory structure allows for a drug considered substandard by one state to be marketed or exported out of another that has not caught up with the quality deficiency. The proposed National Drugs Database may help remedy this. Without legally-binding codes on drugs transport, from the manufacturing unit to the point-of-sale/shipping, and on safe storage along the value-chain, quality issues are going to persist. The new Drugs, Medical Devices and Cosmetics Bill missed addressing this. A standardised quality benchmark is also needed—drug makers today adhere to different quality protocols depending on the market they serve.
