Drug makers may fall under NDPS Act

In a reversal of its two-year-old decision to avoid from the purview of the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, the finance ministry, which administers the Act, has once again proposed compulsory registration of all medicine manufacturers and dealers that handle drugs that contain narcotic and psychotropic substances before the Central Bureau of Narcotics (CBN). CBN comes under the revenue department of the ministry.

The proposal comes after the ministry felt that by keeping drug manufacturers away from the scrutiny, the Central government agencies are finding it difficult to have information on the quantities of psychotropic substances manufactured, consumed in the country.

The range of medicines that contains psychotropic ingredients covers pain-killers, anti-depressants and sedatives. Industry sources feel that the movement of medicines worth Rs 500 crore to Rs 1,000 crore will come under NDPS scanner once the new proposal gets through.

Anti-depressants like alprazolam and diazepam, analgesics (medicines used to relieve pain) like nitrazepam, epilepsy medicines like phenobarbitone and common anaesthesia medicines like buprenorphine all contain psychotropic substances, they said.

The All India Organisation of Chemists and Druggists (AIOCD), the apex body of over five lakh medicine traders of the country, has decided to oppose the government move.

"We have formed a sub-committee to decide our strategy. We will never allow ourselves to be subjected to additional regulation as we are selling all drugs after securing mandatory licences from the state drugs control departments. We do not sell narcotic drugs or psychotropic substances, we sell medicines", A N Mohan, president, AIOCD, said.

Meanwhile, official sources point out that the decision was taken after the state drug controllers, who regulate manufacture and trade of all pharmaceuticals, including psychotropic substances, failed to provide the details of the production and movement of narcotic and psychotropic substances.

The move is aimed at improving regulation of psychotropic substances through non-intrusive methods and collect statistics and estimates of psychotropic substances, they explain.

Under the UN Convention on Psychotropic Substances 1971, India is obliged to provide details of the movement of psychotropic substances to the International Narcotics Control Board on a regular basis.

The ministry's plan is to amend the NDPS Rules to enforce compulsory online registration and filing of returns by manufacturers, wholesalers and distributors of psychotropic substances.

The trade and the manufacturing sector will be asked to file half-yearly returns of the movement in prescribed formats.

The proposal, first mooted in 2005, had invited wide spread protests from across the drug trade community.

The medicine retailers had even stopping taking stocks of all medicines that contain psychotropic substances, thereby, leading to apprehensions of shortage of these medicines in the market.

The government decision to avoid drug traders from the ambit of the law was a result of the protests.

UNDER SCRUTINY

All India Organisation of Chemists and Druggists (AIOCD), the apex body of over five lakh medicine traders of the country, has decided to oppose the government move

The Central government agencies were finding it difficult to find information on the quantities of psychotropic substances manufactured and consumed in the country

The range of medicines covered includes pain-killers, anti-depressants and sedatives

Under the UN Convention on Psychotropic Substances 1971, India is obliged to provide details of the movement of psychotropic substances to the International Narcotics Control Board on a regular basis