UP Govt Orders Strict Action Against Counterfeit Medicines, Fake Licences & Illegal Drug Networks

Lucknow, August 24: The Yogi Government has further intensified its crackdown on the illegal trade of counterfeit, substandard, adulterated and narcotic medicines in the state. To ensure that patients receive safe and quality medicines, strict monitoring will now be carried out from the issuance of drug licences to the storage of medicines, billing practices and the entire supply chain.

The government led by Chief Minister Yogi Adityanath has issued detailed guidelines for effective action against illegal businesses operating under the cover of drug sale licences, licences obtained in the names of dummy individuals, fake billing, stock manipulation and networks dealing in counterfeit medicines. In serious cases, action will not remain limited to the Drugs and Cosmetics Act, but FIRs will also be registered under the relevant provisions of the BNS and NDPS Acts.

The SOP issued by Food Safety and Drug Administration Commissioner Dr. Roshan Jacob defines the responsibilities of Drug Inspectors and Licensing Authorities. Under the new system, special monitoring will be carried out for codeine syrups, painkillers, fast-moving and high-value medicines, as well as medicines falling under the NDPS category. In cases involving suspected medicines, backtracking will be conducted not only of the entire purchase and sale chain but also of bank transactions and digital records.

A thorough verification of the applicant and the firm's background will be conducted before issuing new wholesale drug licences. Individuals previously involved in illegal drug trade will be prevented from obtaining fresh licences in the names of their spouses, siblings, parents, other close relatives or dummy persons. Serious violators will be debarred from obtaining licences. The role of their business partners and associates will also be examined. In addition, drug sale licences will not be issued to establishments located in residential areas. Physical inspections will ensure that the premises for which the licence is sought are genuinely being used for commercial activities.

Inspections will also verify whether the shop or establishment is being operated by the actual licence holder or whether another individual is conducting business in the licence holder's name. Bank accounts, GST registration and other legal documents must also be in the name of the licence holder. If it is established that a business is being operated by another person using a licence issued in the name of a woman or any other individual, action including suspension, cancellation of the licence and prosecution will be initiated.

Strict action will also be taken if medicines are found stored without a licence in basements, residential houses or rented rooms separate from the licensed premises. Investigations will therefore not remain confined to the shop alone but will also examine potential locations where medicines may actually be stored.

Ledger stock and actual stock of fast-moving and high-value medicines such as diabetes medicines, hypertension medicines, antibiotics, cancer drugs and painkillers will be matched. If discrepancies are detected, investigations will be conducted into purchases, sales, and the source of the medicines. Activities such as purchasing medicines from a firm and reselling them to the same firm, selling medicines at abnormally low prices, cross-billing among a limited number of local vendors, or adjusting stock only on paper will trigger investigations extending up to the manufacturer level. In cases involving suspected medicines originating from other states, physical verification of manufacturers and suppliers will also be conducted through Drug Inspectors of the concerned states.

Under the Yogi Government's new system, billing software used in the pharmaceutical trade will also be examined. Activities such as maintaining negative stock, back-dated billing, deletion of data, maintaining dual accounts or concealing actual stock will be treated seriously. During raids, CCTV DVRs, e-way bills, transport receipts, photographs of batch markings and seals on blister packs, statements of concerned individuals and other digital records must be preserved as evidence. Examination of bank transactions will be carried out to determine between whom actual payments and supplies took place behind paper transactions.

Labels, spellings, names, formulas, batch numbers, manufacturing and expiry dates, addresses of manufacturers or marketing companies, vial and blister packaging, size and security features of suspected medicines will all be examined. If differences are found when compared with samples of the original medicine, sale of the product will be stopped immediately and samples will be sent to the Government Analyst. If a valid source of the medicine is not found or the concerned manufacturer denies having manufactured it, the medicine will be treated as counterfeit/spurious and legal action will be initiated. Upon confirmation in the Government Analyst's report, a joint FIR will be registered under the Drugs and Cosmetics Act as well as the relevant provisions of the BNS, 2023.

If it is established that medicines supplied under government programmes, ESI, defence supply, physician samples or expired medicines have been relabelled and sold in the market, the concerned stock will be taken into custody and an FIR will be registered.

If cold-chain products such as insulin and vaccines are found stored at normal temperatures instead of the prescribed temperature range of 2 to 8 degrees Celsius, they will also be taken into custody and action will be taken in accordance with the rules. If irregularities are found in inter-district or inter-state purchase bills, the actual source of the medicines will be investigated. If links, collusion or billing loops among multiple firms are detected, all firms connected to the network will be subjected to simultaneous intensive investigation. The objective is not merely to seize suspected stock but to expose the entire supply chain of counterfeit and illegal medicines and identify the role of every individual involved.

If counterfeit or spurious medicines are confirmed or serious irregularities are detected, the sale and distribution of the concerned medicines will be stopped immediately. Along with seizure of stock, action will be taken for suspension or cancellation of the licence. The order must be served upon the licensee within a maximum of one working day. After cancellation of the licence, all purchase and sale transactions involving medicines by the concerned firm will be completely stopped. Disposal of stock will be permitted only after verification of valid purchase records. If documents are not available, the entire stock will be taken into government custody.

Special surveillance will be maintained on the illegal purchase and sale of codeine syrups, painkillers and medicines falling under the Narcotic Drugs and Psychotropic Substances (NDPS) category. If investigations establish the involvement of an organised network or organised crime, action will not remain confined to drug laws alone. Cases will also be registered under the relevant provisions of the BNS, 2023 and the NDPS Act.

The FSDA has directed all Drug Inspectors to strictly comply with every provision of the SOP and avoid unnecessary delays in investigations so that evidence is preserved and effective legal action can be ensured against those involved in the trade of counterfeit, substandard, adulterated and illegal medicines.