The US Food and Drug Administration (FDA) has pulled up Gujarat-based Goran Pharma, a company that specialises in oral care and pain relief products, over serious violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals. The US federal agency issued a warning letter to the company after inspecting its manufacturing facility at Sihor in November and finding the company’s response to the charges inadequate.

Goran Pharma products include herbal and calcium toothpaste, various oral care medicines, denture fixatives, pain relieving ointments and balms. Its annual toothpaste production capacity stands at 1,500 tonnes. An email query sent to the company seeking comment on the issue has gone unanswered.

During inspection, FDA investigator observed that the firm failed to ensure the identity of components, including active ingredients and excipients from various suppliers, and did not test incoming components used in manufacturing drug products to determine their conformance to identity, purity, strength and other appropriate specifications.

“Your firm released components for use in drug product manufacturing based on certificates of analysis (CoA) from your supplier without establishing the reliability of the suppliers’ analyses through appropriate validation. For example, your firm did not test each lot of glycerin used as a component of your drugs to determine whether diethylene glycol (DEG) or ethylene glycol (EG) was present. Because you did not test each glycerin lot using the United States Pharmacopoeia (USP) identification test that detects these hazardous impurities, you failed to assure the acceptability of lots used in drug product manufacture,” the FDA stated in its warning letter to the company.

DEG contamination in pharmaceuticals has resulted in various lethal poisoning incidents worldwide.

In its response to the charges, Goran Pharma indicated that it would compare its laboratory results with the supplier’s CoA to confirm the reliability of testing for all lots and provided a revised standard operating procedure (SOP).

“Your response is inadequate because it is not clear whether you will indefinitely test each incoming component lot for all attributes to verify the accuracy of your suppliers’ CoA, or you will instead qualify your suppliers’ test results through an initial round of testing as well as ongoing testing at appropriate intervals. Additionally, your response did not address whether your firm conducted retrospective DEG and EG testing for products distributed to the US,” the warning letter added. According to the FDA, the manufacturer has also failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials and drug products. Its quality unit is accused of releasing batches without reviewing all production and control records and shipping batches prior to completion of microbiological testing. The company is also urged to engage a third-party consultant to assist it in meeting cGMP requirements.

According to a study report released this year by Indian Pharmaceutical Alliance and consultancy firm McKinsey, there is drastic reduction in the number of Indian pharmaceutical plants getting warning letters from the FDA thanks to a renewed focus on automation, staff training and collaboration with regulators. The number of FDA inspections in India declined from 272 in 2015 to 192 in 2017 and the share of plants receiving a clearance without adverse observations increased from 32 per cent to 51 per cent.