The Maharashtra Food and Drugs Administration (FDA) has issued a notice to Cipla Pharma and Life Sciences (CP&LS) to recall their product Reactin Plus from the state. The action follows the company's advertisement of the Schedule H drug, which is a prescription-only medication and cannot be directly promoted to the public under the law.
FDA Action and Seizure
Joint Commissioner of the FDA (Drugs), Pune division, Girish Hukare, stated that the notice was issued after packets of Reactin Plus were discovered stocked in a godown in Wadki, Pune. The packaging advertised the drug as an analgesic and anti-inflammatory medicine, which violates section 74 (p) of the Drugs and Cosmetics Act, 1940. The FDA has instructed CP&LS in Mumbai and the drug manufacturer for Cipla HSN International in Haridwar to recall the drugs from all channels across Maharashtra, including carrying and forwarding agents, stockists, distributors, wholesalers, retailers, e-commerce platforms, and online marketing outlets.
The notice was issued on June 13 following the seizure of the Schedule H drug valued at Rs 11.2 lakh in Pune. Reactin Plus oral tablets combine diclofenac sodium (50 mg) and paracetamol (325 mg). Alongside the recall, the notice demands a compliance report within a week and the publication of consumer information messages in newspapers. Failure to comply will lead to appropriate action by the FDA.
Recall Plan and Compliance
A copy of the FDA notice, reviewed by a TOI reporter, requires a detailed recall plan within 48 hours of issuance. This plan must include product and batch-wise distribution details, quantity manufactured and supplied, names and addresses of distributors and stockists, methodology and timeline for recall, and proposed corrective actions. Hukare mentioned that the FDA is yet to receive a response from CP&LS. The notice has also been sent to the Drugs Controller General of India and the State Drugs Controller of Uttarakhand for further action.
TOI attempted to contact CP&LS's corporate communication team via email and text message but received no response by the time of publication.
Separate Operation Against Tramadol Misuse
In a related operation, a joint team of the state FDA and the anti-narcotics cell I, Pune, conducted a major crackdown on drug misuse. Acting on a tip-off, officers arrested a 28-year-old man for illegally selling the prescription medicine Spas Trascen Plus, which contains dicyclomine hydrochloride, tramadol hydrochloride, and acetaminophen, without a license. The seller and supplier were arrested for possessing tramadol, while authorities continue to investigate the distribution network and logistics chain. A criminal case has been registered at the Bund Garden police station under relevant sections of the Narcotic Drugs and Psychotropic Substances (NDPS) Act.
During the raid at a premises on Tadiwala Road, inspectors recovered 10,492 capsules packed in 73 boxes, containing 424.06 grams of tramadol valued at Rs 68,328. This quantity falls within the commercial quantity for controlled substances under the NDPS Act, 1985. Tramadol is a potent opioid-like analgesic, and its misuse without medical supervision can lead to severe physical and mental harm and increased addiction. FDA Commissioner of Maharashtra, Tukaram Munde, emphasized that the misuse of drugs like tramadol fosters addiction among youth and poses a serious threat to public health, warning that strict action will be taken against all elements involved in the illegal supply chain.
