Tides in Indian pharma, by Levin Thomas.

POOR CLINICAL STUDIES ON NEWLY APPROVED DRUGS IN INDIA.

Medical journal Lancet has reported that certain medicines are being aggressively marketed in India despite inadequate evidence of safety and efficacy, putting patients at severe risk.  The famous sensational article which throws a dark shade on the new drug approval process in our country is authored by Anoop Misra and Atul Luthra of the Delhi-based Fortis C-DOC (Center of Excellence for Diabetes, Metabolic Diseases, and Endocrinology). The article has reported that studies on three recently-introduced drugs in the Indian market are lack of rigorous trials on crucial safety and efficacy parameters and are mostly been funded by pharmaceutical companies marketing them that are likely to be biased.

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. While Saroglitazar is marketed as Lipaglyn by Zydus Cadila (approved in June 2013) for high cholesterol, Hydroxychloroquine, marketed as Bioquin by IPCA Labs (approved in July 2014), and Berberine by Sushrut Ayurved Industries, are being used for diabetes.

Before a drug is launched in India, it is required to do studies to prove its safety and therapeutic effectiveness, according to regulation. 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 the treatment of cholesterol and diabetes in India.

Elaborating on Saroglitazar, the article reports that 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 randomized 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 case of Berberine — a combination of herbal traditional extracts and minerals, there were no trials reports pertaining to the drug’s safety and effectiveness from India . 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.

Hydroxychloroquine has been used for the treatment of rheumatoid arthritis for long. In the case of use of hydroxychloroquine for diabetes , only one published study was done however and  the lead author was an employee of IPCA Labs, the manufacturer of the drug, who funded the study. 

Sl.No.	Drugs	Indications
1	Pasireotide solution for injection 0.3mg/0.6mg/0.9mg	For the treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative
2	Emphagliflozin Tablet 10mg/10mg	As an adjunct to diet and exercise to improve glycemic Control in adults with Type 2 diabetes Mellitus.
3	Gadobutrol solution for injection	In adult, adolescence and children aged 2 years and older for:        1.Contrast enhancement in cranial and  spinal magnetic resonance imaging  (MRI).   2. Contrast enhancement MRI of other body regions: liver kidneys.   3. Contrast enhancement in Magnetic Resonance Angiograpy (CE-MRA) 4. For MRI of the breast to assess the  presence and extent of malignant breast
4	Teneligliptin Tablet 20mg	For the treatment of Type 2 Diabetes Mellitus as a monotherapy adjunct to diet and Exercise