How the regulator failed to bring killer cough syrup maker to task

In January 2020, severely ill children from Jammu were taken to Chandigarh’s Postgraduate Institute of Medical Education and Research (PGIMER), where the cough syrup was found to have diethylene glycol, a toxic industrial solvent that attacks kidneys. The children who consumed the ColdBest syrup suffered acute kidney injury, and the results of tissue biopsies from the kidneys were consistent with diethylene glycol poisoning.

In such cases, a criminal complaint under the Drugs and Cosmetics Act is the first step towards initiating legal proceedings against the offending company.

The Himachal drugs regulator hasn’t taken such a step yet, and the state’s high court has blocked a move to stop Digital Vision from selling medicines.

Delays in bringing errant drugmakers to book aren’t unusual in India. According to Kundan Lal Sharma, a former joint secretary in the health ministry, the 36 drug regulators of India prosecute only a “minuscule" number of the substandard-drug cases identified by them. The state regulators are hamstrung in their attempts to build strong legal cases because of a lack of training, inadequate staffing, and pressure from local politicians and the industry.

As a result, victims of substandard drugs rarely get justice. A glaring example is the 1986 case in which 14 patients died in Mumbai’s Jamsetjee Jejeebhoy Hospital after consuming glycerine contaminated with diethylene glycol. The case launched by the Maharashtra Food and Drug Administration against the manufacturer is still before the Girgaon Metropolitan Magistrate Court.

In the Digital Vision case, the PGIMER doctors informed India’s apex drug regulator—the Central Drugs Standard Control Organisation (CDSCO)—and the Himachal regulator of their findings in February 2020. This led to the Himachal regulator inspecting the manufacturer’s premises and finding multiple quality control failures.

In July that year, another two-year-old from Baddi, Himachal Pradesh, died after consuming the Cofset brand of cough syrup, also manufactured by Digital Vision and contaminated with diethylene glycol, according to findings of PGIMER doctors.

Despite Digital Vision’s many documented transgressions, Himachal regulatory officials told Mint that they were facing challenges in building a case against the company.

According to them, when drug regulatory labs analysed several samples from the batch of ColdBest PC that the children consumed, some contained diethylene glycol, while others didn’t. The regulator claimed that this raised questions about whether the manufacturer adulterated the syrup or another party did so. Further, the officials said that the failure to conduct autopsies on the deceased children had made it difficult to link their deaths to diethylene glycol.

“It is a complicated case. So, we want to file the case after taking all things into consideration so that no lacuna is there at a later stage," said Garima Sharma, assistant drug controller, Himachal Pradesh Drug Control Administration, when asked about the delay in filing a case.

Sharma didn’t answer a question on why the Himachal regulator did not request autopsies after PGIMER informed them in February 2020 about the adulteration. CDSCO head V.G. Somani didn’t respond to a similar question.

The Himachal drugs regulator has also struggled to shut down operations of Digital Vision, despite the seriousness of the ColdBest case.

Even though the regulator ordered the company to stop manufacturing all drugs on 17 February 2020, the company appealed the order in the Himachal Pradesh high court.

In August 2020, the high court quashed the order, arguing the regulator had not demonstrated the company’s negligence in manufacturing drugs other than the tainted cough syrup. However, the court upheld the regulator’s order to stop manufacturing products containing propylene glycol.

Propylene glycol was the solvent used in ColdBest PC that had been adulterated with diethylene glycol.

An email sent to Parshottam Goyal, managing director of Digital Vision, did not elicit a response at the time of publication.

Mint had previously reported that Digital Vision’s drugs had failed quality tests 19 times before the ColdBest deaths. Yet, the Himachal regulator treated the company leniently. In March 2021, government testing found another of Digital Vision’s anti-allergy drugs, Nycyp syrup, to contain less than the required amount of a key ingredient, cyproheptadine. In response, the Himachal regulator merely suspended the firm’s licence to sell the product for 60 days.

Kundan Lal Sharma said the inability of state drug regulators to bring cases to court quickly is a longstanding problem that poses a major public health threat. In his book, Healing the Pharmacy of the World, Lal has suggested several solutions. Key among them is to unite India’s 36 regional regulators into a single one. Sharma argues that such a central regulator is more likely to be insulated from state-level political and industry pressures and can have a dedicated, trained wing to prosecute cases. Today, state drug regulators enjoy too much discretion about whom to prosecute and when to do so. “As long as prosecution remains in the power of state governments, this problem is likely to continue."