Himachal: Spurious injection among 31 failed drug samples
In a major setback to Himachal Pradesh’s pharmaceutical industry, 31 drug samples manufactured by firms in the Baddi-Barotiwala-Nalagarh (BBN) industrial belt and Kala Amb region have failed quality tests conducted by the Central Drugs Standard Control Organisation (CDSCO). The failed samples account for 25.6 per cent of the 121 drug samples declared “Not of Standard Quality” (NSQ) across the country in April.
According to the monthly drug alert issued by CDSCO, critical quality parameters such as dissolution, assay, identification, sterility, particulate matter and pH levels were found to be non-compliant in several medicines manufactured in Himachal.
The list of failed samples includes tablets, capsules, seven injections, five syrups and nutritional supplements containing calcium and vitamins. In many cases, the Active Pharmaceutical Ingredient (API) was found to be below the prescribed standards, raising concerns over the efficacy of the medicines. Some medicines reportedly failed to dissolve properly in the body, while several injections did not meet mandatory sterility and particulate matter norms.
In an alarming development, a Diclofenac Sodium injection manufactured by a Baddi-based pharmaceutical unit was declared “spurious” under Section 17-B of the Drugs and Cosmetics Act. The sample reportedly failed identification and quantitative content tests for Diclofenac and was also found to contain Buprenorphine, an opioid drug. Another drug manufactured by a Kala Amb-based company was categorised as “misbranded” by the central regulator.
The CDSCO carries out routine nationwide sampling and testing of medicines to monitor drug quality and identify potentially unsafe products. Drugs that fail prescribed standards are included in a monthly public alert issued by the organisation.
State Drug Controller Dr Manish Kapoor said that under the revised World Health Organisation (WHO) manufacturing schedule, stricter quality compliance measures had been introduced in the pharmaceutical manufacturing process. He said the department was focusing on improving quality standards and minimising instances of failed samples. He also urged consumers and healthcare professionals to regularly check the CDSCO website for alerts relating to substandard or suspicious medicines.
Apart from Himachal Pradesh, 24 drug samples from Uttarakhand, 20 from Gujarat, seven from Telangana and five from Sikkim also failed quality tests during April. Samples from Haryana, Uttar Pradesh, Karnataka, Rajasthan, Maharashtra, Punjab, Jammu and Kashmir, Tamil Nadu, Puducherry, Bihar and West Bengal were also found to be substandard.
