New Delhi: The government is all set to bring Tramadol, a painkiller, under the ambit of the Narcotics Drugs and Psychotropic Substances (NDPS) Act in a move aimed at checking its abuse. Penalties for violations of provisions will increase substantially and a notification is likely to be issued soon, two people aware of the matter said.

The Narcotics Control Bureau (NCB) raised concerns about the abuse and trafficking of pharmaceuticals in a recent meeting held at the Central Drugs Standard Control Organization (CDSCO) and suggested that the availability of Tramadol be substantially reduced in order to track its movement in the market.

At the Drug Consultative Committee (DCC) meeting held on 9 April, the NCB suggested manufacturing of Tramadol and codeine-based cough syrups in small batches to enable authorities to track the manufacturer. It was also suggested “to verify the existence of sale premises before a licence is granted by the states and to conduct surprise raids in this regard. NCB, requested all the state licensing authorities to re-consider proposal of reduction in batch size for manufacturing such drugs to control the diversion towards its abuse and misuse," said the minutes of the meeting, reviewed by Mint.

According to the NCB, these formulations are widely available and are being abused. In July last year, the NCB had suggested that these pharmaceutical preparations be sold “state-wise" according to specific batch/lot sizes and that this information should be printed on their labels, the way alcoholic beverages such as beer are sold.

To keep a strict vigil on its movement, the government has now decided to bring Tramadol under the ambit of NDPS Act. The NDPS provides for strict imprisonment and fine for offenders. “NDPS Act treats drug offences very seriously and penalties are stiff, whereas Drugs and Cosmetics Act deal with the quality of the drug," said a senior government official on condition of anonymity.

“The drug should be under restrictions of production as API (active pharmaceutical ingredient) and controls on import into and export out of India. This will ensure the availability of the drug to the person who needs it for pain management and also restrict its illicit movement," added the minutes.

Significantly, the NCB had earlier last year also taken up the issue of abuse of pharmaceutical preparations in a review meeting with the minister of state for home. At that time, the Border Security Force had seized bottles of Phensedyl near the India-Bangladesh border. The bottles were to be smuggled into Bangladesh, where these cough syrups are banned.

“During the investigation of the cases the point of diversion could not be established as the lot size of drugs is big and same lot size is distributed to many stockists/distributors in different states," the NCB had written to the Drug Controller General of India then.

Major pharmaceutical firms making preparations based on Tramadol include Zydus Cadila, Aurobindo Pharma Ltd and Sun Pharmaceutical Industries Ltd.

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