New Delhi: The government is considering regulating the sales of anticonvulsant drug Pregabalin, following concerns over the misuse of the commonly available medicine. It has invited comments as it proposes to restrict the sales of the drug to a prescription from a registered medical practitioner.
Pregabalin is likely to be put under the category of Schedule H1 drugs, according to people familiar with the matter.
The Drugs and Cosmetics Rules, 1945, target certain medications such as third and fourth generation antibiotics, anti-tuberculosis drugs and some psychotropic drugs, requiring stricter control and monitoring due to their potential for misuse.
The government has given 30 days to the affected parties to give suggestions and raise objections.
At present, drug formulations containing Pregabalin do not come under the ambit of either Schedule H or Schedule H1 of the Drugs Rules, 1945. While Schedule H drugs require a registered doctor's prescription, Schedule H1 requires pharmacies to maintain records of both patients and prescribing doctors.
The misuse of the drug and its preparations had raised alarm bells among policymakers, prompting the government to consider stringent measures to regulate its sales, said the people.
Drug formulations containing Pregabalin are generally prescribed by doctors for the management of neuropathic pain, to treat fibromyalgia. Pregabalin capsules and tablets are used along with other medications to treat certain types of seizures among adults and children over the age of one month.
Earlier, the Food and Drugs Administration, Punjab, had alerted the drug regulator that drugs formulations containing Pregabalin 150 mg and 300 mg were being misused for intoxication.
Pregabalin is likely to be put under the category of Schedule H1 drugs, according to people familiar with the matter.
The Drugs and Cosmetics Rules, 1945, target certain medications such as third and fourth generation antibiotics, anti-tuberculosis drugs and some psychotropic drugs, requiring stricter control and monitoring due to their potential for misuse.
The government has given 30 days to the affected parties to give suggestions and raise objections.
At present, drug formulations containing Pregabalin do not come under the ambit of either Schedule H or Schedule H1 of the Drugs Rules, 1945. While Schedule H drugs require a registered doctor's prescription, Schedule H1 requires pharmacies to maintain records of both patients and prescribing doctors.
The misuse of the drug and its preparations had raised alarm bells among policymakers, prompting the government to consider stringent measures to regulate its sales, said the people.
Drug formulations containing Pregabalin are generally prescribed by doctors for the management of neuropathic pain, to treat fibromyalgia. Pregabalin capsules and tablets are used along with other medications to treat certain types of seizures among adults and children over the age of one month.
Earlier, the Food and Drugs Administration, Punjab, had alerted the drug regulator that drugs formulations containing Pregabalin 150 mg and 300 mg were being misused for intoxication.