USFDA Warns Indian Homoeopathy Firm

New Delhi, 3 April 2019: The US Food and Drug Administration (FDA) has sent a warning letter to a leading Indian homoeopathy medicine manufacturer after “spotting” insects at its factory and “finding a live moth floating in its raw materials”.

The FDA has now directed the company — the Noida-based B.Jain Pharmaceuticals — to ensure “immediate correction” and respond to its letter within 15 working days.

B.Jain Pharmaceuticals exports homoeopathy medicines to several countries, including the US, where it has partnered with popular drug stores such as CVS and Walgreens. In India, the firm sells a variety of products for the treatment of piles, diabetes, liver ailments, anaemia, blood purifiers and even baby products that are available on popular e-pharmacy websites such as 1 Mg, NetMeds and HealthMug.

The FDA had inspected the company’s manufacturing unit at Bhiwadi in Rajasthan between 13 August and 29 August 2018. The watchdog’s letter, dated 21 March 2019, states that during the inspection, investigators found that the “the firm failed to keep the medicines free of infestation by rodents, birds, insects, and other vermin”.

“In the raw material storage room, our investigator observed numerous flying insects. FDA observed your staff dispensing raw material for use in production… and a live moth was observed floating in this raw material,” reads the letter.

“When the investigator pointed out the presence of this moth in your raw material, you continued to manufacture homoeopathic drug products using the raw material contaminated with the insect.”

Taking note of the FDA letter, the Indian drug regulator is also gearing up for an inspection.

“We will conduct a thorough inspection on the company’s products in the market and its manufacturing sites,” Vaidya Rajesh Kotecha, secretary, Ministry of Ayush, told ThePrint.

B.Jain, however, told ThePrint that it has begun addressing the issues.

“In reference to the warning letter received we have taken a serious note of the concerns brought up and will be submitting all evidence to FDA for all corrective actions taken and preventives which were done when this concern was noticed,” the firm’s CEO, Nishant Jain, told ThePrint. “We are also re-testing (in-house as well as outsourced ) to check products control samples.”

The company further said that raw material, which was contaminated, was a one-off instance and was immediately destroyed. “Water system loopholes found were remedied and a re-validation of the system was initiated,” it said.The Print