For several decades now it has been fashionable to spout opinions in conferences and in media about what can be done to boost India’s exports. While all sorts of policy measures have been tried, it is relatively clear that as a nation we struggle to get the basics right on quality control because of our weak law enforcement mechanism. The Marion Biotech case study is the latest in a long line of disasters where medicines made in India cause fatalities elsewhere in the world with little or no repercussions for the manufacturers. Prateek Goyal writes:
“Marion Biotech, the Indian company linked to the deaths of 68 children in Uzbekistan, allegedly operated through a network of shell companies, forged documents, and bribes. Its owners were never brought to book.”
Mr Goyal then gives us more colour on the man in the centre of this mess: “In a photograph on the Facebook page of his family foundation, Sachin Jain looks every part the concerned philanthropist — light green shirt, neat spectacles, a smile on his face, talking to children about personal hygiene. It is a carefully composed image of a man of social purpose, working for underprivileged children.
Scratch the surface and a different picture emerges. Jain owns Marion Biotech Private Limited, a pharmaceutical company whose cough syrups a Tashkent court found responsible for the deaths of 68 children in Uzbekistan between 2022 and 2023. Sixteen more were left with disabilities.”
Mr Goyal then gives us the punchline: “But Jain has never been convicted. He hasn’t even spent a single night in custody in either Uzbekistan or India. In fact, with more than 20 companies spanning pharmaceuticals and real estate under his and his family members’ directorship, Jain’s corporate machinery has continued to operate largely undisturbed.”
So how did Sachin Jain get away it? Prateek Goyal’s article gives a step-by-step account of this disaster and if you read it you will realise that the fault lies with how our legal system works.
All the kids who died in Uzebekistan in 2022 had consumed Dok-1 Max Syrup manufactured by Marion Biotech. Mr Goyal writes: “Indian authorities were informed as soon as contamination was confirmed. By December 27, Uzbekistan banned the drugs. India’s Central Drugs Standard Control Organisation (CDSCO) began coordinating with Uzbek regulators. A joint inspection by CDSCO and the Uttar Pradesh Drugs Control Department at Marion Biotech’s Noida plant led to a production halt.
On December 30, a show cause notice was issued to Marion Biotech asking why their licence should not be cancelled. On January 10, 2023, Uttar Pradesh suspended the company’s manufacturing licence. On January 11, the World Health Organisation issued a global Medical Product Alert stating that Dok-1 Max and Ambronol contained “unacceptable amounts” of toxic substances. Samples sent by central and UP regulators to the Regional Drugs Testing Laboratory (RDTL) in Chandigarh returned alarming results for Dok-1 Max: one sample had 15.87 percent EG, another had 34.28 percent EG, a third had 29.32 percent EG and 4.09 percent DEG, and a fourth had 24.97 percent EG and 8.36 percent DEG.
On March 2, 2023, CDSCO officials filed an FIR at the Noida Phase-3 police station against Marion Biotech directors Sachin Jain and Jaya Jain, and employees Tuhin Bhattacharya, Atul Rawat, and Mool Singh. It was lodged under various sections of the Drugs and Cosmetics Act 1940. While the three employees were arrested the next day, the Jains left India for the UAE.
Later that month, the Uttar Pradesh Food Safety and Drug Administration permanently cancelled Marion Biotech’s licence on March 13. The Drugs Controller General of India (DCGI) later confirmed that 24 of 33 cough syrup samples tested were not of standard quality; 22 were declared adulterated or spurious. From June 1, 2023, the Indian government made certified testing mandatory for all exported cough syrups.”
So far, so good. It looked as if India might be finally getting its house in order in terms of quality control. However, “Despite arrests, global alerts, lab findings, and a court order identifying Marion Biotech’s owner as having played a role, Jain was never arrested either in India or Uzbekistan. In fact, things soon returned to normal for the company.” So, how did this happen?
Prateek Goyal’s article highlights bribery in Uzbekistan followed by prison sentences in that country for those who worked for Sachin Jain. But back home in India, something more interesting happened: “After the FIR was lodged against them in Noida in March 2023, Sachin Jain and his wife Jaya moved the Allahabad High Court seeking the quashing of the case.
The next month, the court granted the couple substantial protection. It told the police not to arrest or prosecute the petitioners and even said the FIR should not have been filed in the first place since it was not a cognisable offence under the Indian Penal Code, and should have been dealt with instead via a complaint before an “appropriate forum”. It refrained from quashing the case citing a Supreme Court direction.
The couple had left India even before this order by Justices Anjani Kumar Mishra and Nand Prabha Shukla.
The High Court later granted the company relief in terms of the licence.
The Uttar Pradesh drug control authority had permanently suspended Marion Biotech’s manufacturing licence on March 13, 2023. In June, Jain appealed before the Appellate Authority, the Special Secretary, Food Safety and Drug Administration, Government of Uttar Pradesh. On September 14, the Drug Licensing and Control Authority permitted the company to manufacture drugs other than syrups requiring propylene glycol.”
There are a few more twists and turns in this sad story of corruption in our corporate and legal ecosystem. Prateek Goyal’s long read traces the narrative carefully. Effectively, whenever one part of India’s legal system dispenses justice effectively, someone else somewhere else is captured to compromise the system and thus nullify its ability to dispense justice.
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