No stone left unturned to deny compensation for 12 infant deaths in J&K

Twelve children in the age group of 45 days to 7 years died in Jammu's Ramnagar area allegedly due to consumption of a highly contaminated cough syrup in the months of December 2019 and January 2020. Some of them died at home, some in hospitals in Udhampur, Jammu and Chandigarh.

Even as out of harsh orders from the National Human Rights Commission (NHRC), the Union Territory administration has paid an amount of Rs 36 lakh - at Rs 3 lakh to each victim's family - a long-drawn legal battle claiming compensation to the sufferers from the manufacturer on the pattern of the Bhopal gas tragedy is still underway. As of now, all the accused are out on bail, and none of them have been penalised in the last two years.

The punishment for manufacturing or trading spurious drugs that can cause death includes 10 years to life imprisonment and a fine to the tune of Rs 10 lakh or three times the value of the drugs confiscated, according to the Drugs and Cosmetics Act, 1940.

Jammu-based social activist Sukesh Khajuria, who pursued the infants' case at the NHRC, says: “In all such deaths, punishment and compensation should be on the pattern of the tragedies of the Bhopal gas leak and the Uphaar Cinema blaze. We can't fix the price of human life at Rs 25-30 lakh in Delhi and Rs 3 lakh in J&K.”

In January 2020, some publications of insignificant circulation carried stories on the death of the 12 infants. Ramnagar falls in the Lok Sabha and Assembly constituencies of the BJP's powerful politicians. A public relations exercise is afoot to suppress or underplay reports that the infants - from the extremely poor families - had died due to consumption of the contaminated cough syrup or criminal negligence of the authorities. The story did not appear in major newspapers either.

According to the complaints filed with the authorities, all the 12 infants with cough and fever symptoms were examined by a local chemist who prescribed and sold them an intake of ColdBest-CP cough syrup manufactured by M/S Digital Vision, Kala Amb, district Sirmour, Himachal Pradesh. As the fatalities in identical conditions went up rather phenomenally, J&K Drug Controller Lotika Khajuria requested her counterparts in Himachal Pradesh to immediately inspect the drug manufacturing unit and collect the samples for a thorough chemical analysis and implement drug recall in “the larger public interest”.

Around the same time, there were similar complaints about some deaths allegedly due to the consumption of the same cough syrup in Haryana.

A team of doctors from the Postgraduate Institute of Medical Education & Research (PGIMER) Chandigarh had detected a poisonous substance, 'diethylene glycol' (DEG), far beyond the permissible level in the cough syrup ColdBest-PC. It was soon confirmed by the Regional Drug Testing Laboratory (RDTL), Chandigarh.

Digital Vision's license was suspended, and the company was stopped from manufacturing the drugs. Immediately after the FIR in Himachal Pradesh, FIR No: 33/2020 Dated 3-03-2020, was filed against the drug manufacturers and traders at Ramnagar Police Station in Jammu's Udhampur district. Before they were arrested, the company owners were granted bail by the Jammu and Kashmir High Court. The High Court in Himachal Pradesh restricted the suspension of the manufacturing to only the alleged contaminated drug and permitted the company's other operations.

According to Himachal Pradesh's State Drug Controller Navneet Marwah, a September 2019 batch of ColdBest-CP was found containing the toxic impurity.

The adulterated batch, manufactured in September 2019 by Digital Vision, contained 5,575 units. Of these, 3,447 bottles were found sold in eight states by the time authorities started withdrawing the batch from the market after an alert by PGIMER in January. Of the remaining 2,128 units, 657 were collected for sampling and 565 returned to the manufacturer. Stocks of 906 units were sealed.

Around 1,350 bottles of ColdBest-CP were found sold in Jammu alone. Only 486 bottles could be recalled.

On 4 March 2020, Himachal Pradesh Chief Minister Jai Ram Thakur said in the State Assembly that batch No: 5201 of ColdBest-CP, manufactured in September 2019, had been found contaminated with 34.97% of DEG as per the report of Government Drug Analyst Chandigarh on 2 March 2020. Besides J&K and Himachal Pradesh, the syrup has also been sold in Uttarakhand, Haryana, Uttar Pradesh, Meghalaya, Tripura and Tamil Nadu.

Thakur said the manufacturer had been booked under section 18(a)(i) of the Drugs and Cosmetics Act, read with section 17(a) dealing with adulterated medicines. These offences are punishable under section 27A, which carries a prison term of 10 years to life. He said that Section 308 IPC, dealing with attempts to commit culpable homicide, had also been added to the FIR.

DEG is used as a solvent in some drugs with a very low permissible level—0.1% to 0.2% in India. According to the reports from Chandigarh, the samples of ColdBest-CP contained 34.97% DEG. Because of its adverse effects on humans, it is not allowed for use in food and drugs in many countries. The US Code of Federal Regulations allows no more than 0.2% of DEG in polyethylene glycol when the latter is used as a food additive. The concentration of the weak acid HEAA and metabolites may cause renal delay, leading to metabolic acidosis and further liver and kidney failure.

According to an article in the Journal of Public Health Policy, the use of DEG has been implicated in at least 12 medication-associated mass poisonings across the globe in the last 70 years. In India, 14 patients in Mumbai died in 1986 after being administered glycerine contaminated with DEG, and in 1998, at least 33 children in Gurgaon died due to DEG poisoning, said a WHO report. It added that in the USA, the deaths of more than 100 people due to similar poisoning were recorded in 1937, leading to stringent legislation on drug safety.

During the proceedings of a court case in Himachal Pradesh, the drug authorities revealed that Digital Vision had acquired DEG from unauthorised dealers in Ambala and Delhi and that it had misinformed about the quality control testing as it had no such facility.

According to Xtended Licencing Laboratory and Legal Node, a database that tracks instances of substandard medicines, there had been seven cases from 2014 to 2019 when drugs manufactured by Digital Vision were found to be “not of standard quality”.

After a two-year-old child's death at PGIMER on 22 July 2020, Central Drug Standard Control Organisation (CDSCO) on 11 August 2020 ordered the recall of another stock of 2,992 bottles of Digital Vision's cough syrup Cofset AT, supplied to Bengaluru, Kolkata, Jagadhri, Jalgaon, Nabha and Sikar through Shiva Medical Hall Ambala. The complaint had been filed by a Professor of Paediatrics at PGIMER Chandigarh.

With five identical FIRs registered in Ramnagar (J&K), Kala Amb (HP), Mahesh Nagar Ambala (Haryana) and Shambu Patiala (Punjab), none of the accused was ever arrested. SSP Udhampur constituted a Special Investigation Team (SIT) which has reportedly established the charges. However, the challan has not been filed in court.

Zaffar Din (26), a labourer in Ramnagar, said that the local chemist Mahinder Singh Jamwal prescribed and sold him the medicine after examining his 3-month-old son Irfan. In 12 days, Irfan died at Jammu's SMGS Hospital. Like all other victims, Irfan stopped passing in the first three days, indicating his renal failure.

Schoolteacher Ashok Kumar's two-and-a-half-year-old daughter Anirudh died at PGIMER Chandigarh. According to Kumar, the post-mortem report and chemical analysis in Chandigarh attributed Anirudh's mortality to ColdBest-PC cough syrup. According to him, the deaths caused by the cough syrup were more than 12 in J&K alone as some, like Ankita (4) of Bishna, who died at PGIMER, had no entries.

Jammu-based advocate Sheikh Shakeel Ahmad appreciated NHRC's action of entertaining Sukesh Khajuria's letter as a formal petition which ultimately resulted in the payment of compensation of Rs 3 lakh to each victim's family.

“But there was no goodwill gesture, ex-gratia or voluntary compensation from the J&K Government. They fought a pitched battle with the petitioner in NHRC and J&K High Court. Lastly, they also filed an SLP against the NHRC in the Supreme Court, making every possible attempt to deny compensation to the victims. The payment was released only after NHRC repeatedly threatened contempt proceedings and called for the Chief Secretary's personal attendance.”

“So far, there have been no arrests of the persons involved or penalty imposed on the manufacturers, traders or the unauthorised chemists. They are all still in business,” Khajuria lamented.

Ahmed Ali Fayyaz is an independent journalist based out of Jammu & Kashmir. With 27 years of experience, Fayyaz is a policy analyst and a political commentator. He has extensively reported on conflict - after the 1990 Kashmir conflict - for the national and international media.