Drugs from Himachal units fail quality test: CDSCO report

Naina Mishra

Chandigarh, October 12

Around 45 samples of medicines were found to be of substandard quality, according to a report of the Central Drugs Standard Control Organisation (CDSCO) released last month.

The CDSCO is the central drug authority for discharging functions assigned to the Central government under the Drugs and Cosmetics Act, 1940. Of the failed samples, Himachal Pradesh-based manufacturing units have more than 13 samples of substandard quality.

Paracetamol among substandard medicines

• Of the 45 failed samples, Himachal-based manufacturing units have more than 13 samples of substandard quality
• The most basic drug, Paracetamol, samples of which were drawn from HP units, was found to be of substandard quality

The samples of the most basic drug, Paracetamol, drawn from several manufacturing units in Himachal have failed the dissolution test. Dissolution testing is important for characterising the performance of oral solid dosage forms. Dissolution testing measures the extent and rate of solution formation from a dosage form, such as tablet, capsule, ointment, etc. The dissolution of a drug is important for its bioavailability and therapeutic effectiveness.

In May this year, the Assistant Drugs Controller and Licensing Authority, New Delhi, had launched an inquiry against Glenmark Pharmaceuticals Limited and declared one of its drugs, Telmisartan (blood pressure medication), as “spurious” under Section 17 B (e) of the Drugs and Cosmetics Act, 1940.

Ofloxacin and Ornidazole, an antibiotic of Mohali-based manufacturing firm, has also failed the “assay test”.

An “assay test” is an investigative procedure for assessing or measuring the presence, amount or functional activity of a drug (the analyte).

Gentamicin injection, another antibiotic injection manufactured by a Chandigarh-based firm, has failed the bacterial endotoxins and sterility tests.

Recently, Nixi Laboratories of Kala Amb, Himachal Pradesh, was under the scanner because one of its drugs, anaesthesia Propofol, failed the quality test. The samples were collected from a pharmacist at the emergency ward of the PGIMER, Chandigarh, following the death of five persons, who were administered the anaesthetic drug during a surgical procedure. The Himachal Pradesh firm has been asked to recall all batches of Propofol.