De-addiction drug deal exposed

Vishav Bharti
Tribune News Service
Chandigarh, January 5

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De-addiction drug buprenorphine, which has emerged as a new kind of addiction in Punjab, is making illegal inroads into the state from pharmaceutical manufacturers in Gujarat and Uttarakhand, it has come to light.

A few months back, Food and Drug Administration (FDA), Punjab, recovered 1.6 lakh tablets of the habit-forming drug from a wholesaler in Ludhiana. Further investigation led to three pharmaceutical companies in Gujarat and Uttarakhand.

As per instructions of the Drug Controller General of India (DCGI), buprenorphine can only be supplied directly to de-addiction centres.

However, as the market is thriving in Punjab, unscrupulous elements are purportedly getting it manufactured from Gujarat and Uttarakhand and selling it illegally to de-addiction centres and chemists.

The medicine is reaching Punjab through lesser-known courier companies, railway transportation and Volvo buses. Last week, Punjab’s FDA teams visited several transport and courier companies and railway authorities to sensitise them.

Acting on a tip-off, the FDA raided wholesaler Oracle Laboratories in Ludhiana where a cache of buprenorphine and a combination of buprenorphine and nalexone tablets worth Rs 46 lakh was recovered. The owner, it was revealed, was getting the medicines from three manufacturers: Talent Health Care, Haridwar (Uttarakhand); Theo Pharma Pvt Ltd in Gandhinagar (Gujarat) and Zenith Healthcare Ltd in Ahmedabad. Not only Punjab, the Ludhiana wholesaler had a supply network in Delhi, Haryana and Rajasthan as well. 

The name of several de-addiction centres and doctors in Rohtak, Sonepat, Jind, Bikaner and Delhi also cropped up during the investigation. However, Vikas Bansal, Director, Oracle Laboratories, claimed he had a valid licence to supply the medicine. “Why have we been singled out when there are at least 15 companies in Punjab doing the same thing?” he questioned.

The state’s FDA has asked Gujarat and Uttarakhand FDAs to investigate, saying the manufacturers were violating the 2010 instructions of DCGI, as per which the manufacturers of fixed-dose combination of buprenorphine and nalexone sublingual tablets can supply only to the designated de-addiction centres and hospitals with de-addiction facility. 

Any other sale channels are banned. Besides that, one brand of medicine (CPCOD-N 0.5mg) was being manufactured by the three companies, which is again a violation of Sections 18(a) and 17-B of the Drugs and Cosmetics Act. The legislation prescribes that one brand of medicine cannot be manufactured by different manufacturers.

The FDA, meanwhile, has cancelled the licence of Oracle Laboratories.

Pardeep Kumar, Joint Commissioner, FDA, Punjab, acknowledged that the way buprenorphine was making way into Punjab was of serious concern. “We are trying to plug all the loose channels,” he said.

Overdose of salt than legally allowed

The Tribune had last year highlighted how Punjab’s de-addiction programme had turned out to be a new addiction as the dose of the de-addiction drug buprenorphine being sold in the state contained an overdose of salt than is legally allowed. The fact came to the fore when the FDA tested the medicines in a laboratory. The medicines pertained to three companies — Addnok, Cizdol, QTRUGS.

What manufacturers have to say

• Mahendra Racha, Managing Director of Zenith Healthcare Ltd, claimed they had not supplied any medicine directly to any distributor in Punjab. He said they have replied to the queries of FDAs of Gujarat and Punjab
• The spokesperson for Theo Pharma Pvt Ltd refused to comment, saying the directors are out of state
• Umesh Patel of Talent Health Care, Haridwar, refused to comment