- Home
- Medical news & Guidelines
- Anesthesiology
- Cardiology and CTVS
- Critical Care
- Dentistry
- Dermatology
- Diabetes and Endocrinology
- ENT
- Gastroenterology
- Medicine
- Nephrology
- Neurology
- Obstretics-Gynaecology
- Oncology
- Ophthalmology
- Orthopaedics
- Pediatrics-Neonatology
- Psychiatry
- Pulmonology
- Radiology
- Surgery
- Urology
- Laboratory Medicine
- Diet
- Nursing
- Paramedical
- Physiotherapy
- Health news
- Fact Check
- Bone Health Fact Check
- Brain Health Fact Check
- Cancer Related Fact Check
- Child Care Fact Check
- Dental and oral health fact check
- Diabetes and metabolic health fact check
- Diet and Nutrition Fact Check
- Eye and ENT Care Fact Check
- Fitness fact check
- Gut health fact check
- Heart health fact check
- Kidney health fact check
- Medical education fact check
- Men's health fact check
- Respiratory fact check
- Skin and hair care fact check
- Vaccine and Immunization fact check
- Women's health fact check
- AYUSH
- State News
- Andaman and Nicobar Islands
- Andhra Pradesh
- Arunachal Pradesh
- Assam
- Bihar
- Chandigarh
- Chattisgarh
- Dadra and Nagar Haveli
- Daman and Diu
- Delhi
- Goa
- Gujarat
- Haryana
- Himachal Pradesh
- Jammu & Kashmir
- Jharkhand
- Karnataka
- Kerala
- Ladakh
- Lakshadweep
- Madhya Pradesh
- Maharashtra
- Manipur
- Meghalaya
- Mizoram
- Nagaland
- Odisha
- Puducherry
- Punjab
- Rajasthan
- Sikkim
- Tamil Nadu
- Telangana
- Tripura
- Uttar Pradesh
- Uttrakhand
- West Bengal
- Medical Education
- Industry
Pregabalin formulations must be sold with prescription: Drugs Control Administration, Telangana
New Delhi: In a significant move to counter the rising abuse of pregabalin, the Drugs Control Administration (DCA) of Telangana has instructed all stakeholders, including retail outlets and hospital-attached pharmacies, that pregabalin formulations must be sold only with a prescription from a registered medical practitioner.
This move is based on reports received by the Drugs Control Administration, Telangana, regarding the abuse potential of the drug Pregabalin, and considering drug literature, including several case reports and epidemiological studies, concerns have been raised about the abuse potential of Pregabalin, the use of which has increased substantially over the last decade.
The drug 'Pregabalin' has been approved in India by the Drugs Controller General (India) for the following indications: the treatment of peripheral neuropathic pain in adults (such as diabetic neuropathy), and the management of fibromyalgia syndrome, either as a single-ingredient formulation or in a fixed-dose combination with Methylcobalamin, Alpha-lipoic Acid, Pyridoxine, and Folic Acid.
Pregabalin is an anticonvulsant drug used to treat neuropathic pain conditions and fibromyalgia, and for the treatment of partial onset seizures in combination with other anticonvulsants.
Pregabalin is structurally similar to gamma-aminobutyric acid (GABA) - an inhibitory neurotransmitter. It may be used to manage neuropathic pain, postherpetic neuralgia, and fibromyalgia among other conditions. Although, as per the FDA label, the mechanism of action has not been definitively characterized, there is evidence that pregabalin exerts its effects by binding to the α2δ subunit of voltage-dependent calcium channels. Pregabalin is marketed by Pfizer under the trade names Lyrica and Lyrica Cr (extended release). It may have dependence liability if misused but the risk appears to be highest in patients with current or past substance use disorders.
Products containing 'Pregabalin' are being manufactured and supplied by most pharmaceutical manufacturers with a boxed caution on the product label, including the primary pack (strip) and carton, stating: CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
Considering the drug literature, which includes numerous case reports and epidemiological studies, as well as reports obtained by the Drugs Control Administration, Telangana, regarding the abuse potential of the medication pregabalin—the use of which has significantly increased over the past ten years—concerns have been raised.
In light of the reports concerning the abuse potential of Pregabalin, the Drugs Control Administration, Telangana, instructs all stakeholders, including retail outlets and hospital-attached pharmacies, that Pregabalin formulations must be sold only with a prescription from a Registered Medical Practitioner.
In addition to the above, the Drugs Control Administration, Telangana, through a notice stated that the details of Pregabalin sales must be recorded in the Prescription Register at the time of supply, and the serial number of the register entry must be noted on the prescription.
The following particulars shall be entered in the 'Prescription Register' for the sale of formulations containing pregabalin:
(a) Serial number of the Entry,
(b) date of Supply,
(c) name and address of the Prescriber
(d) name and address of the Patient,
(e) name of the drug and quantity,
(f) Supplied manufacturer's name, batch number, and date of expiry of potency,
(g) Signature of the registered pharmacist who supplied the medicine or under whose supervision it was supplied.
Furthermore, the notice added, "The above instructions shall be strictly adhered to. Failure to comply with these instructions will attract punishment under the Drugs and Cosmetics Act, 1940, and the Rules made thereunder."
Doctor of Pharmacy
Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751