28 drug samples manufactured in HP-based firms found substandard

As many as 28 drug samples manufactured by 26 pharmaceutical firms of the state were among 145 drugs declared not of standard quality by the Central Drugs Standard Control Organisation (CDSCO) in its monthly alert issued last evening. This amounts to 19 per cent of the total drug samples declared not of standard quality.

Of the 145 drug samples declared not of standard quality, the CDSCO had analysed 52 while various states tested 93 samples. Among the 26 firms, 16 are located in Solan district with a majority of them being third party manufacturers in Solan city and its periphery. The remaining firms are located in Kala Amb and Paonta Sahib in Sirmaur district and Kangra district.

Besides causes like inadequate assay that hits the efficacy of a drug, the failure in the dissolution and disintegration tests were identified as the major reasons for drugs failing quality parameters. The presence of particulate matter in injections is considered a serious defect that brings the manufacturing practices under a cloud. If injected, such an injection can cause inflammation, tissue damage or allergic or immunogenic reactions, say health experts.

Among the commonly used drugs that figure on the list were Cefixime and Ofloxacin tablets, Ocuex Eye drops, Nutribest-Plus, Ofloxacin and Ornidazole tablets, Rebast-ARD, Solikast-L, Hyoscine Butylbromide tablets, Aceclofenac, Paracetamol and Serratiopeptidas tablets, Wincold Z, Megaceclo MR and Rizdox-200 tablets.

Bronkorex AM Syrup used to treat cough with mucus lacked the requisite assay. The CDSCO was specially targeting cough syrups and injections along with drugs used to treat common ailments as they are sold in large volumes. Three batches of Mupirocin ointment used to treat skin infections did not conform to Indian Pharmacopeia’s specifications. It is manufactured by three different firms.

Drugs, which figured on the list, are used to treat a host of common ailments like urinary tract infection, eye infection, niacin deficiency, bacterial and parasitic infections, short-term fluid replacement after trauma or dehydration, allergic skin conditions, pain due to smooth muscle spasm, pain, common cold, inflammation and other ailments.

Several injections like Rabeprazole Sodium, which is an anti-ulcer medicine, were found to contain particulate matter while Ciprofloxacin injection, used to treat bacterial infections like pneumonia, urinary tract infections and infections in your bones and skin, and Ceftriaxone injection used for bacterial infection, were also on the list.

State Drugs Controller Manish Kapoor said that drug batches that figured on the list would be immediately withdrawn from the market and their manufacturers would be served notices. The field staff would examine the laxity that led to sub standard dug manufacturing.

As part of continuous regulatory surveillance, the CDSCO picks drug samples from sales/distribution points, analyses them and issues monthly alerts to create awareness among stakeholders about the batches identified as not of standard quality. States also follow a similar exercise to identified drug samples that fail quality parameters.