New Delhi: 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.
A number of violations, says FDA letter
The FDA’s letter has highlighted the state of affairs at the company, which claims to be in the business for over four decades.
According to the letter, the ceiling of the room where the medicines were being manufactured had probably caught fungi. “In addition, various raw materials, some packaged in burlap sacks, were observed scattered across your quarantine room,” the letter reads.
It further states that the firm risked the lives of consumers by keeping very close together two different raw materials. “Leaking containers of one raw material were observed in close proximity to other raw materials in your warehouse,” the letter states.
The FDA also allegedly found that the company is not conducting “microbial testing” — compulsory testing of products to confirm that the final medicines are sterilised and free from any kind of contamination. “Given the state of disrepair of your system, the investigator asked for your system’s microbial test results for 2018, which you were unable to provide,” the letter states.
The regulator has asked for a review of the company’s pest control and manufacturing procedures to ensure that its manufacturing areas are free from insects or other vermin. It has also asked the company to perform the risk assessment for all drug products distributed in the US market that used raw materials potentially contaminated with insects or other vermin.
‘Came into business to save homoeopathy’
B.Jain Pharmaceuticals, which claims to have begun its operations in 1966, describes itself as a “pharmaceutical plant with a difference”.
“The difference would be quality with transparency,” reads a note compiled by the company’s research and development head, Dr Geeta Rani Arora, on its website.
The company’s website also claims that it follows both Indian and Canadian Good Manufacturing Practices (GMP) — an internationally recognised benchmark for quality assurance.
“Strict cleanliness and access control are maintained in the sections where medicines are prepared. The entire plant is centrally air-conditioned; all entrances to the plant have air curtains,” the company claims on its website. “The water used in the plant is sourced from its in-house RO cum Demineralization unit. Following the GMP standards in letter and spirit, raw materials whether plant, animal or chemical based are all obtained from trustworthy sources.”
- The copy has been updated with the response from B.Jain.