Maharashtra’s Food and Drug Administration (FDA) has canceled the drug sales and distribution license of pharmaceutical company Cipla Pharma and Life Sciences Limited’s Pune-based warehouse. The FDA has taken this action after several irregularities were found at the company’s carrying and forwarding (C&F) warehouse located in Pune’s Vadki. The FDA, in a statement issued on Friday, said the decision was taken after completing a fresh legal process following the directions of the Bombay High Court. The Assistant Commissioner (Drugs) of FDA’s Pune Division-3 issued a fresh order canceling the license on October 1.

Earlier on August 27, FDA also took action against the same warehouse. During that time, irregularities in the packaging, storage, documentation and withdrawal process of Cipla ‘Reactin Plus’ tablets were revealed. The FDA took action after unauthorized promotional claims on drug packets and several warehouse defects were discovered.

However, following the Bombay High Court’s instructions, the FDA withdrew its earlier action and started the process afresh. The department issued a revised show cause notice to the company on September 4. The company filed its written reply on September 11 and was also given an opportunity for personal hearing on September 21. The FDA passed the new order after reviewing the company’s response, arguments presented at the hearing, the inspection report and available documents.

There is an irregularity in the packaging of Reactin Plus

According to the FDA, during a warehouse inspection, claims were found on the packaging of ‘Reactin Plus’ tablets which described it as a painkiller and relieves headache, muscle pain, back pain, joint pain, sprains, body aches and toothache. This drug is a prescription drug falling under Schedule-H. The FDA also found a human figure and a picture of the muscle pain reliever on the packaging.

According to the department, the claims, words and images used on the packaging were not in accordance with the relevant legal provisions. This was considered a case of misleading packaging (false branding) under the Drugs and Cosmetics Act, 1940. The FDA stated that a company responsible for marketing a drug cannot escape its legal obligations by merely citing the role of the manufacturer.

Many defects were also found in the warehouse

The FDA inspection also revealed several deficiencies in drug storage and warehouse management. These include non-availability of prescribed Form-35 check book, lack of adequate pallets and racks, storage of medicine boxes directly on the floor and accumulation of dust on medicine stock.

Apart from this no separate place was fixed for keeping the expired medicines, which were marked ‘expired-not for sale’. Necessary standard operating procedures (SOP) and records related to disposal of expired drugs were also not available.

The FDA also found purchase bills, duplicate copies of sales bills, and discrepancies between computer or SAP records and actual stock. In which stock of antibiotics was also included. Reference was made to maintain records in SAP and other computer systems by the company. However, the FDA clarified that keeping computer records does not end the licensee’s legal liability. It is the responsibility of the company to provide proper storage of drugs, cleanliness, matching of actual stock and necessary documents for inspection.

After the instruction of the High Court, a fresh action was taken

The FDA clarified that the October 1 order is not a repeat of the August 27 proceedings, but an independent regulatory decision taken after completing the entire process again under the directions of the Bombay High Court. FDA Commissioner Tukaram Mundhe said the purpose of the department is not just to take action, but to ensure the safety and quality of drugs and to ensure compliance with legal provisions in the drug supply chain. He said that the action was taken in full compliance with the instructions of the Bombay High Court in accordance with the principles of natural justice, transparency, opportunity of hearing and decision-making process based on proper reasons.