EVERY third drug in the Indian domestic market is manufactured in Himachal Pradesh, and the state’s pharmaceutical industry is pegged at Rs8,000 crore. Of the 625 manufacturers in the pharma hubs, 139 have been given licences to produce pharma-opioids/psychotropic substances, listed in the schedule of the Narcotic Drugs and Psychotropic Substances (NDPS) Act.
In the absence of any nationwide survey to gauge an estimate of genuine users of these narcotic and psychotropic drugs, meant for therapeutic purposes, the pharmaceutical companies continue to upscale manufacturing to cater to the ever-increasing demand for recreational purposes. This illegal diversion for the nefarious use of a sizeable chunk of pharma-opioids has besmirched the image of Himachal’s pharma hubs, which prided themselves in manufacturing Covid vaccines and medicines in recent months.
The latest case of a Baddi-based wholesale trader, Zannet Pharmaceuticals, indulging in illegal sale amounting to Rs100 crore of narcotic drugs like Nitrazapem, Codeine and Etizolam through fake bills and firms has exposed the chinks in the open-ended licensing policy. That the trader’s wholesale drug licence had been cancelled in Punjab in 2018-19 and the Rajasthan drug control administration did not bother to provide details regarding the firm to the local authorities expose glaring loopholes in the system.
Several such cases have also surfaced in Paonta Sahib and Kala Amb in Sirmaur district, facilitating the illegal entry into the market of pharma opioids like Tramadol in Punjab and other states, with sales running into crores. There are 14 NDPS drugs which are manufactured for therapeutic use, of which three — Alprazolam, Codeine and Tramadol — are widely misused for recreational purposes and by addicts, as per the seizure pattern of the police.
Instead of devising a stringent licensing system that ensures restricted and controlled production, the open-ended system results in units manufacturing tablets coming out with scheduled NDPS drugs as well. The absence of effective inter-state and inter-departmental coordination further fuels sales, as departments like State Taxes and Excise and Directorate General of Goods and Service Tax Intelligence have little or no coordination with the Drug Control Authority (DCA).
The DCA did wake up after the anomalies came to fore during cases unearthed recently in Baddi, Kala Amb and Paonta Sahib.
“Standard operating procedures have been devised where a manufacturing unit is supposed to file monthly returns of narcotic substances consumed and balance stocks, as well as details of drugs manufactured and sold before the State Drugs Controller,” says Navneet Marwaha, the State Drugs Controller. It has also been made mandatory to provide information to the Drugs Inspector and the Superintendent of Police of the district about the drugs dispatched from a unit, and the destination. About 25 units have surrendered their NDPS licences following this intervention.
The moot question, however, remains whether these measures are enough, considering the high level of penetration in North India, where drug abuse is higher than the national average. As per a recent survey conducted by the National Drug Dependence Treatment Centre, AIIMS-Delhi, as against the national average of 0.7 per cent, the use of opioids is 2.8 per cent in Punjab, 2.5 in Haryana, 2 per cent in Delhi and 1.7 per cent in Himachal Pradesh.
Vinod Gupta, a manufacturer with 42 years of experience in the field, says only “thorough scrutiny of returns by officials by randomly tracking the backward and forward linkages can help track nefarious elements”, who, he adds, tarnish the image of manufacturers. “There is an overwhelming demand for such NDPS drugs, but given the stringency to provide various details, I’ve restricted manufacturing from about 10 to three,” he adds.
Experts say there is no alternative to a more rigid licensing system, under which manufacturers and traders who face cancellation of licence in one state for violating the Drugs and Cosmetics Act should not be permitted to operate in other states as well.
Sharing his concerns over the nefarious trade, Rajesh Gupta, president of the Himachal Drug Manufacturers Association, says, “Restrictions should be enforced at retail shops, too, with only a select few chemists in a given area being permitted to sell such drugs. This will help check malpractices.”
He points out that several manufacturers who have limited staff and infrastructure to maintain records and follow requisite procedures are now surrendering their licences after the state DCA has stepped up regulatory checks.
Another area of concern is the lack of inter-departmental and inter-state coordination. The Department of State Taxes and Excise (DSTE) is the administering department for NDPS Act in Himachal. It issues ‘MD 6’ licence for manufacturers and traders dealing in NDPS and psychotropic substances. The staff of the DSTE, however, failed to detect fake bills through which the trade proliferated for more than two years by Zannet Pharmaceuticals at Baddi.
Himachal DGP Sanjay Kundu claims strict enforcement of drug laws, particularly concerning the misuse of pharma-opioids by pharmaceutical companies. “They are now on our radar. Financial investigation under the NDPS Act for attachment of illegally acquired properties is being undertaken. The inputs are shared with the Enforcement Directorate to investigate money laundering,” he says.
“We are focusing on the big fish and undertaking robust investigations and effective trial management. Tracing the backward and forward linkages by involving senior officials in search and seizure operations is lending a knockout punch to the criminals,” he adds.
DGP Kundu says Register Number 29 has been introduced at all police stations to profile criminals involved in narcotics and psychotropic substances crimes.
Key drug seizures
On May 29-30 this year, in a joint operation with the Punjab Police, the HP Police seized over 30 lakh intoxicant tablets, including 12.4 lakh Tramadol capsules, 7.7 lakh Tramadol tablets and 9.9 lakh Alprax tablets worth Rs15 crore, from Unique Formulations, Paonta Sahib. Its marketing company, PB Pharmaceuticals, New Delhi, was non-existent. The police also recovered 745 kg of raw material for Tramadol worth Rs3 crore.
In 2019, Apple Field Pharma Company, Paonta Sahib, was shut on directions of the HP Police State Narcotics Cell for an unaccounted stock of 47,000 Tramadol tablets and 10,000 Codeine-based cough syrup bottles. Investigations revealed that the proprietors/shareholders of Unique Formulations and Apple Field Pharma were the same.
On May 31, Orison Pharma International, Kala Amb, was found manufacturing tablets containing Tramadol which were sold to a marketing company, PP Pharma in Ahmedabad, without any agreement in violation of the Drugs and Cosmetics Act. During inspection, 30 lakh Tramadol tablets and 226 kg of raw material were seized.
On information from Interpol in Benin (Africa), an FIR was registered against Laborate Pharmaceuticals, Paonta Sahib, for alleged illegal export of 1.75-crore Tramadol tablets worth around Rs5 crore (approximately Rs100 crore in the illegal market) to Chad.
Clearly, the magnitude of the illegal trade presents a huge challenge.
HOW IT ALL BEGAN
It was the 2003 Central industrial package which gave a major push to the pharma investment in Himachal, by giving
exemption in Central excise duty, income-tax holiday and subsidy on capital investment. This earned the industrial hub of
Baddi-Barotiwala-Nalagarh the sobriquet of being the pharma hub of Asia. Top companies opened their units here.
Drugs misused most
Etizolam, Alprax Sedatives used to treat depression
Codeine Cough syrup
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