Yogi administration issues guidelines for safe, quality medicines
Lucknow, August 24: To ensure safe and quality medicines reach patients, strict monitoring will now be in place, from the issuance of drug licenses to drug storage, billing, and the entire supply chain, the Yogi Adityanath’s government has issued detailed guidelines for effective action against illegal trade under the guise of drug sales licenses, licenses in the name of dummy individuals, fake billing, stock manipulation, and counterfeit drug networks. In serious cases, action will not be limited to the Drugs and Cosmetics Act, but FIRs will also be filed under relevant sections of the NDPS and NDPS.
The standard operating procedure (SOP) issued by Roshan Jacob, Commissioner of the Food Safety and Drug Administration (FSDA), defines the responsibilities of drug inspectors and licensing authorities. Under the new system, special monitoring will be conducted on NDPS-listed drugs, including codeine syrup, painkillers, fast-moving and high-value medicines. In the case of suspicious drugs, the entire purchase-sale chain, including bank transactions and digital records, will be backtracked.
For new wholesale drug licenses, the applicant and the firm will undergo thorough background verification. Individuals previously involved in the illegal drug trade will be barred from obtaining new licenses in the names of spouses, siblings, parents, other relatives, or dummies. Additionally, drug sales licenses will not be issued to establishments located in residential areas.
If government-supplied, ESI, defense supplies, physician samples, or expired drugs are found to be relabeled and sold in the market, the relevant stock will be seized and an FIR will be filed. Cold chain products, such as insulin and vaccines, found stored at room temperature instead of the prescribed 2 to 8 degrees Celsius, will also be seized and action will be taken as per the regulations. If discrepancies are found in inter-district and inter-state purchase bills, the actual source of the drug will be investigated. If mutual connections, nexus, or billing loops between multiple firms are discovered, all firms involved in the network will be thoroughly investigated simultaneously. The objective is not only to seize suspicious stock, but also to expose the entire supply chain of counterfeit and illegal drugs and the roles of those involved.
Upon confirmation of a counterfeit or spurious drug, or upon the discovery of a serious irregularity, the sale and distribution of the drug will be immediately halted. Along with seizing the stock, the license will be suspended or revoked. The order must be served on the licensee within a maximum of one working day. Following the license cancellation, the purchase and sale of drugs from the concerned firm will be completely stopped. Disposal of the 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.
