Himachal Pradesh: How Spurious Drugs Have Brought Bad Name, Regulatory Spotlight On State’s Famed Pharma Industry

The Baddi-Barotiwala-Nalagarh industrial belt in Himachal Pradesh’s Solan district is among Asia’s largest pharmaceutical hubs. The state takes pride in it but the image of pharma belt has taken a hit in recent years over quality concerns and recoveries of spurious drugs.  

The Solan-based pharma companies have not just attracted the ire of the central and state regulatory but have also led to criminal prosecution. 

The belt has nearly 700 top pharma companies, including industry leaders like Dr Reddy, Torrent Pharma, Alkem Pharmaceutical, Cipla, Sun Pharma, Unichem, Glenmark, and USV.

Failing safety standard tests in pandemic

In February 2022, nine medicines manufactured by Himachal-based pharma companies —majority of them in Solan— failed to meet safety standard tests of the Central Drugs Standard Control Organisation (CDSCO), India’s apex drug regulator. 

The drugs that failed the test include favipiravir used for the treatment of Covid-19. The other drugs are used in the treatments of heart attack, gastric issues, gout, and high blood pressure.

The nine companies were slapped with notices by the Himachal’s drug controller, who also asked the companies to withdraw the entire batches of these medicines from the market.

Earlier in July 2021, Himachal’s pharmaceutical industry came under cloud following allegations that a few firms were involved in illegal drug rackets. 

The Punjab Police raided units at Paonta Sahib and Kala Amb in Sirmaur district and found that tramadol —an opioid painkiller— manufactured by Orison Pharma was being marketed by Mumbai-based PP Pharma that only existed on paper. The Punjab Police made arrests and recovered 30 lakh capsules valued at Rs 15 crore.

Such cases continue to worry the leading manufacturing companies in Himachal along with the state government. 

The Udhampur tragedy and Himachal connection

While raids and seizures have raised concerns in recent years, the most serious case is related to the deaths 12 infants in Ramnagar in Udhampur district of Jammu and Kashmir between December 2019 and January 2020. The children allegedly died after consumption of “unchecked spurious syrup” manufactured by a Himachal-based company.

The police investigation found that the children died due to presence of diethylene glycol in Coldbest-PC Syrup —a common cold medicine— in higher percentage .The medicine was manufactured by Sirmaur-based Digital Vision.

Suresh Chandra Khajooria, a veteran social activist in Jammu, who led a relentless struggle to get the infants’ deaths fully investigated, tells Outlook it has been established by lab reports that the syrup was contaminated and contained 34 per cent diethylene glycol, a toxic compound.

Previous Himachal Chief Minister Jairam Thakur also said this earlier on the basis of preliminary investigations by the police and State Drug Authority. The issue was raised in the Himachal assembly in 2020 by MLAs who wanted stringent action against the manufacturers.

Khajooria says though a compensation of Rs 3 lakh each has been paid to the families by the Jammu and Kashmir administration at the intervention of National Human Rights Commission (NHRC), there is still no closure to the matter. Three years on, the culprits, including erring company, have not been punished so far. He says it is also manufacturers' liability to pay commission to the families. 

An FIR was lodged against Digital Vision by the police and stock was seized but the company resumed operations after a brief halt.

Superintendent of Police Sirmaur Raman Kumar Meena says FIR number 21/2020 under sections 17 (a), 18 (a), and 27 (a) of Drugs and Cosmetics Act and section 308 of the Indian Penal Code —culpable homicide— was registered against five persons, including promoters of the company. 

“The challan has already been filed in the Court of Chief Judicial Magistrate (CJM),” says Meena. 

Companies under scanner for substandard drugs

The pharmaceutical companies, barring some multi-nationals, have been under scanner for clandestinely manufacturing and supplying sub-standard, spurious, and banned drugs in various markets of the country. The role of the enforcement and regulatory bodies have also come under question whenever such cases have come to fore.

A senior journalist, who exposed some of the rackets forcing the agencies to act, says “The role of traders supplying raw materials and active pharmaceutical ingredients (API) to fake units has never been investigated to effectively check manufacture of spurious drugs or banned medicines.”

Spurious drugs worth Rs 1.50 crore were seized from a warehouse at Baddi on November 22, 2022 and an unauthorised manufacturing unit was sealed by the officials on November 24.

Three persons, the alleged kingpin Mohit Bansal of Uttar Pradesh’s Agra, Atul Gupta of UP’s Auriaya resident, and Vijay Kaushal of Madhya Pradesh’s Indore, were arrested under the Drugs and Cosmetics Act, 1940, for manufacture of spurious drugs.

State Drug Controller Navneet Marwah says it was the first time an entire drug trail was smashed by the State Drug Authority and arrests were made at Agra in Uttar Pradesh. The company —Trizal Formulation— was manufacturing spurious drugs unauthorised without taking requisite permissions to manufacture any kind of drugs.

The seized drugs belonged to leading companies like Cipla, Zydus, Cadila, USV Private Limited, and IPCA Laboratories, among others.

In December 2022, Central Drugs Standard Control Organisation also alerted all drug licensing authorities (DLAs) across the country to check the circulation of spurious medicines manufactured by Baddi-based Trizal in the name of various renowned companies. The recoveries of the spurious drugs included montair-10 tablets useful for asthma, 1.90 lakh tablets of Zerodol TH4 used as muscle relaxant, and Roseday-10 and vitamin D supplements.

Taking a serious note of the reports about drug manufacturing units in the state playing with lives of the people by manufacturing spurious and substandard drugs, the High Court had sought complete details from the government and steps taken to check the abuse of manufacturing facilities.

The High Court also noted with pain that illegal business of spurious drug trade was flourishing in the Baddi-Barotiwala area of Solan district and curbing such activities had become a challenge.

Rajendra Guleria, President of Baddi-Brotiwala-Nalagarh Industrial Association, says he was in favour of strongest action against the persons involved in the manufacturing of spurious drugs whether in Baddi-Brotiwala or elsewhere. He says the enforcement agencies should be alert and act whenever any such information is received.

“Seizure of spurious drugs was made by the State Drug Controller of unlicensed premises. Some outsiders used to indulge in such malpractices with the help of large company’s experienced employees. They copy big brands and do all nonsense on rented premises,” says Rajesh Gupta, President of Himachal Drug Manufacturers Association.

He adds, “Due to 50 sq km area of Baddi-Barotiwala-Nalagarh hub, it’s very tough to identify such type of crooks. They obtained printed materials from neighbouring state and did the same. It’s a very important and one of few identified markets of India famous for sale of such type of copy products.”

Meanwhile Jammu-based veteran activist Khajooria says he will continue to fight for justice for families of 12 infants so the guilty are jailed soon. 

He says, “Soon, I will also file a case in NHRC to seek enforcement of compensation of Rs 3 lakh each for the next of kin. Most families are poor and have no powerful voice. The role of the government and law enforcement agencies continues to be highly disappointing towards such a tragedy.”