Samples of 25 drugs manufactured in HP found substandard

As many as 25 drug samples, including 11 injectibles, manufactured at 18 pharmaceutical units of Himachal Pradesh have been declared substandard by the Central Drugs Standard Control Organisation (CDSCO) and various states.

These figure among the list of 70 drug samples declared not of standard quality (NSQ).

With several drugs manufactured in the state regularly figuring in this monthly list, the quality of drugs manufactured in the state has come under the scanner.

The list released today is part of the continuous regulatory surveillance where drugs samples are picked from sales/distribution points and analysed. These drugs were manufactured at Baddi, Nalagarh, Paonta Sahib, Kala Amb, Solan and Kangra. Three drug samples tested by other states also figure in the list.

Among the injections declared substandard are oxytocin (for controlling bleeding after childbirth), calcium gluconate (for enhancing calcium level), promethazine hydrochloride (preventing allergy), Celofos 1,000 (for treating bladder inflammation and cancer), Kefzone-S (for urinary tract infection), Casidtaz-P (for bacterial infection) and Nurofens 2,500 (to treat vitamin B12 deficiency).

Besides these, ceftriiaxone and gentamycin sulphate injections, both manufactured by a Paonta Sahib-based firm, have been declared substandard. These injections are used to treat bacterial infections. Two batches of heparin sodium injections, which prevent formation of harmful blood clots, manufactured by a Kala Amb-based firm, have also been declared substandard.

These injections lack the requisite assay content, hitting its efficacy. The assay content in one such injection was as less as 23.26 per cent. “Presence of any adulterant like particulate matter renders the product injurious to health and is termed as a grossly substandard by the CDSCO,” said a drug official. The injections also suffer from description related flaws. However, this is considered a minor error.

Other substandard drugs comprise Neurotem-NT, B-Cidal 625 tablet, trypsin, bromelain & rutoside trihydrate tablets, glipizide tablets, mimesulide and paracetamol tablets, ciprofloxacin tablets, cefpodoxime tablets, Nopion-150 tablets, DM cough syrup and torsemide tablets.

These are used to treat common ailments like nerve pain, bacterial infection, pain, diabetes, depression and smoking addiction, dry cough and fluid retention in the body.

State Drugs Controller Manish Kapoor said they were closely regulating the manufacturing through regular inspections where compliance was ensured in firms lacking regulatory parameters. He said a firm in Nalagarh was ordered to stop manufacturing following certain flaws that were noticed during an inspection. At least three drugs of the firm figure in the current NSQ list.

“Joint inspections by the state and central authorities are underway on a random basis to ensure compliance of the revised Schedule-M guidelines where firms are also undertaking voluntary upgrade of their manufacturing facilities,” said Kapoor.

The batches figuring in the list would be withdrawn from the market while the erring firms would be issued notices to ensure requisite compliance, said the official.