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Indians face risk from unproven drugs: Lancet -Rupali Mukherjee
-The Times of India

MUMBAI: Certain medicines are being aggressively marketed in India despite inadequate evidence of safety and efficacy, putting patients at risk, said reputed medical journal Lancet.

Highlighting weak regulation and monitoring of the domestic drug industry, three recently-introduced medicines are being prescribed and sold though there is a lack of rigorous trials on crucial safety and efficacy parameters. The pharmaceutical industry in India should face the same stringent regulations as elsewhere in the world, rather than continuing to allow patient safety to be put at risk by unproven drug treatments, says an article shared exclusively with TOI.

Though the Lancet analysis refers to case studies of only three medicines — Saroglitazar, Hydroxychloroquine and Berberine — it raises serious questions on the overall quality of drugs being manufactured, besides enforcement of rules and monitoring. Before a drug is launched in India, it is required to do studies to prove its safety and therapeutic effectiveness, according to regulation.

While Saroglitazar is marketed as Lipaglyn by Zydus Cadila for high cholesterol, Hydroxychloroquine, marketed as Bioquin by IPCA Labs, and Berberine by Sushrut Ayurved Industries, are being used for diabetes.

The article authored by Anoop Misra and Atul Luthra of the Delhi-based Fortis C-DOC (Center of Excellence for Diabetes, Metabolic Diseases, and Endocrinology) says, studies (on these drugs) have mostly been funded by pharmaceutical companies marketing them, and are likely to be biased. "Rigorous efficacy and safety evaluation are important so that these drugs do not lead to harm to patients, since adverse effect profiles in patients with diabetes have been inadequately studied," they said.

When contacted, a spokeswoman from Zydus Cadila that manufactures Saroglitazar said: "The drug was introduced after 12 years of clinical trials and completion of necessary investigations required for any new chemical entity, as per government regulation. The drug protocol was reviewed by the government's investigational new drug committee and multi-centre trials were done by independent investigators in 50 centres. Further, an independent data safety monitoring body was constituted. There have been no adverse reactions of the drug. Now, Saroglitazar is prescribed by 4,000 doctors to one lakh patients."

Well-designed trials which are not funded by pharmaceutical companies should be done over a period of one or two years on different category of patients (elderly people, those at high risk for cardiovascular disease and renal dysfunction, etc.) to properly assess these and other new drugs for diabetes in India, the article adds.

Industry experts say the process of approval needs to be made more stringent and rigorous, with large-scale trials, monitored by independent committees and investigators. For instance, globally, trials to introduce a new drug (new chemical entity) typically involve 10,000 to 20,000 subjects, and, post-marketing studies are also conducted after the launch.

Elaborating on Saroglitazar, it says little evidence exists for its efficacy and safety, and overall, the manufacturers have not addressed safety issues adequately in human trials. Only two short-term studies (12 or 24 weeks) have been done, with fewer than 500 patients in total in two random controlled trials. Both studies were funded by the pharmaceutical company marketing the drugs, and in one study, the lead author was an employee of the company. Overall, clinical data for Saroglitazar are clearly inadequate for it to be used with confidence.

In the second medicine, Berberine — a combination of herbal traditional extracts and minerals — no trial from India has been reported. It has not been officially introduced as an antidiabetic drug in India, however, it is available and being actively promoted for this use, among physicians and on the internet.

In the third case, Hydroxychloroquine — normally used for treatment of rheumatoid arthritis — was approved as an anti-diabetic drug in January 2015. In this case, only one published study was done, while the lead author was an employee of IPCA Labs, the manufacturer of the drug, who also funded the study. A questionnaire sent to the company was unanswered at the time of going to press.