Notices sent to12 firms in Himachal over quality issues

The samples of medicines manufactured in Himachal whose samples have failed include medicines and injections for the treatment of cancer, heart disease, infection, fever, vomiting, gastric, edema, cholesterol, pneumonia and stomach worms

The Central Drugs Standard Control Organisation (CDSCO) has exposed a grave lapse in pharmaceutical quality control. As many as 14 medicines and injections, manufactured by 12 pharmaceutical industries in Himachal Pradesh, have failed to meet established quality standards. Among these, three medicines lacked proper labelling, one was misbranded and a Mumbai-based company’s product was found to be fake.

The samples of medicines manufactured in Himachal whose samples have failed include medicines and injections for the treatment of cancer, heart disease, infection, fever, vomiting, gastric, edema, cholesterol, pneumonia and stomach worms. The lapses came to the fore during the first week of December and the last week of November.

The drugs were manufactured in Baddi, Barotiwala, Nalagarh — the biggest pharma hubs in the country. The strand drugs manufacturing came to the fore during a drug alert for November issued by CDSCO.

The fallout extends beyond Himachal Pradesh, as 52 medicines manufactured in Maharashtra, Madhya Pradesh, Uttarakhand, Punjab, Gujarat, Uttar Pradesh, Gujarat, Rajasthan, Telangana, Andhra Pradesh, Chennai and South Korea were also found to be substandard during the CDSCO investigation. These medicines, ranging from treatments for cancer and heart disease to infections and fevers, are now under scrutiny.

The state drug controller has taken immediate action and issued notices to all the erring pharmaceutical companies involved in the drug alert and has issued instructions to immediately recall the entire batch of the concerned drug from the market. The assistant drug controllers have been asked to conduct a joint inspection of all the pharmaceutical industries. Orders have been given to submit a detailed investigation report.

The drugs that failed to meet the quality standards include ondansetron and doxorubicin hydrochloride used to treat cancer, including cefixime, azithromycin tablets, paracetamol, albendazole, spironolactone tablets, fenofibrate capsules, doxylamine succinate, pyridoxine hydrochloride and folic acid tablets and cipro loxacin tablets. Injections are also included. The state drug controller said the 13 people involved in the manufacturing of fake medicines have been arrested this year and strict action has been taken to stop this menace in the state.

State drug controller Navneet Marwah confirmed that show-cause notices have been issued to the pharmaceutical companies and instructions have been given to the drug manufacturer to recall the entire stock of the concerned batch.

Baddi, Barotiwaala and Nalagarh are the largest pharma hubs of Asia, and Himachal Pradesh is the pharmaceutical manufacturing hub of the country. Almost all the leading pharma giants have set up their units here or are in the process of setting up one. An ultra-modern laboratory assisted by the National Institute of Pharmaceutical Education and Research (NIPER) is also proposed to be set up at Baddi. Himachal Pradesh contributes 35.0 %of pharma demand in India.

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