There is rampant sale of the banned painkiller dextropropoxyphehne (DXP) in Pune and elsewhere in the state.

The Food and Drugs Administration (FDA) officials, in a two-week operation, have nabbed a drug consignee agent and a pharma company’s depot manager in Pune. Together, they had sold capsules containing the drug worth over Rs 60 lakh in Pune, the rest of Maharashtra and Goa, officials said.

The agent was nabbed on Thursday night in Uruli Devachi. He was attached to a Hyderabad-based pharma company and distributed the drug through a network spread in Maharashtra and Goa.

FDA officials have filed an FIR against the agent with Loni Kalbhor police station under section 26 (A) of Drugs and Cosmetics Act 1940 and section 328 of Indian Penal Code (causing hurt by means of poison, with intent to commit an offence).

Section 26 (A) of Drugs and Cosmetics Act, 1940 empowers the central government to prohibit manufacture, distribution and sale of a drug and cosmetic, if it involves risk to human life, in public interest. An overdose of the drug acts as a narcotic and it was banned in India this May after reports of its abuse came up.

"The drug consignee agent in Uruli Devachi was found to have sold 1.66 lakh capsules containing dextropropoxyphehne in June alone. The Union government suspended its manufacture, distribution and sale in India in May 2013. Despite knowing this, the distributor deliberately floated a huge amount of capsules containing the banned drug worth over Rs 14.10 lakh in the market to make profit. Dextropropoxyphehne has a narcotic effect and can be harmful when taken in large doses. It can easily be abused by an addict," said B R Masal, joint commissioner (drugs), FDA, Pune.

Drug inspector Rohit Rathod, who conducted the raid under the guidance of assistant commissioner D S Chavan, said that 65 mg and 100 mg capsules containing dextropropoxyphehne can relive pain and act as a medicine, but more than 135 mg acts as a narcotic and can be easily used by addicts.

Medically, dextropropoxyphehne was used as a pain reliever and to reduce fever, and to treat gastrointestinal spasm, irritable bowl syndrome, peptic ulcer, flatulence and diarrhoea.

"It takes the powder from just two capsules with dextropropoxyphehne to act as a narcotic. It was easy for anyone to abuse the drug, hence it was banned after instances surfaced from different parts of the country," Rathod added.

In a similar case, the FDA officials, on July 29, had filed an FIR against a pharma company and its depot manager when they found that capsules containing dextropropoxyphehne worth Rs 47 lakh was sold after the Union government’s ban came into effect. "The pharma company sold all the capsules to its drug distributors in Maharashtra and Goa. These capsules are now in the market. We are trying to recall them," Rathod said.

ABOUT THE DRUG

• For 27 years, since 1985, India has been the second largest consumer of dextropropoxyphehne (DXP)
• When the drug was banned in the US and the EU countries in November 2010, India became the largest consumer
• Between 2001 and 2007, more than 17% of suicidal deaths due to poisoning in the UK were documented to be due to dextropropoxyphene. It was never considered as an agent for suicide in India
• European Medicines Agency had recommended its withdrawal across the EU in 2009, saying the drug's risks, particularly potential fatal overdose, are higher than its benefits
• Some experts feel dextropropoxyphehne should be considered as a special drug and made available on humanitarian grounds with clear guidelines and a strong note of caution. It is inexpensive and accessible and can help hundreds of patients in India where stringent rules deny access to opioids, including morphine. Opioids are pain-relieving medications

NOTIFICATION ON DXP

• The Union government announced the ban in a Gazette Notification on May 23, 2013
• It suspended manufacture for sale, sale and distribution of dextyropropoxyphene and formulations containing dextropropoxyphene as its use is likely to involve risks to human beings
• The notification clarifies the ban is due to harmful effects, but medical professionals believe it is due to misuse of the drug by addicts
• The sale of the drug showed a huge spurt in the Northeast. The drug was under the scanner of authorities for some time after it was banned in the West