Mumbai, Oct 2 (SocialNews.XYZ) The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale and distribution licences of Cipla Pharma & Life Sciences Ltd's carrying and forwarding (C&F) warehouse in Wadki, Pune, citing a series of alleged regulatory violations related to drug packaging, storage conditions, inventory management and documentation.
The licence cancellation order was issued on October 1 by the Assistant Commissioner (Drugs), Division 3, Pune, following a fresh review conducted in accordance with directions from the Bombay High Court.
The latest action comes after earlier proceedings initiated against the facility on August 27 were withdrawn and reconsidered under a revised regulatory process.
According to the FDA, the earlier action had raised concerns over the packaging and promotion of Reactin Plus Tablets, a Schedule H prescription medicine.
The regulator alleged that the product packaging contained unauthorised claims and highlighted several shortcomings in warehouse operations, including storage practices, record maintenance and procedures for handling expired medicines.
Following the High Court's directions, the FDA issued a revised show-cause notice to Cipla on September 4. The company submitted its written response on September 11 and subsequently appeared for a personal hearing on September 21.
After examining the company's submissions, inspection reports, records and applicable legal provisions, the licensing authority issued a fresh order revoking the licences.
The regulator said the latest decision represented an independent determination based on the findings of the renewed proceedings and was not merely a reiteration of the earlier action.
A key focus of the FDA's review was Reactin Plus. According to the regulator, the medicine's packaging described it as an analgesic and listed multiple uses, including relief from headache, muscular pain, backache, joint pain, sprain, body ache and toothache. The FDA also objected to the use of a human figure and visual depictions suggesting relief from muscular pain.
The agency alleged that the claims, wording and illustrations on the packaging did not comply with statutory requirements and amounted to misbranding under the Drugs and Cosmetics Act, 1940.
The regulator further stated that Cipla's responsibilities as the marketer of the product could not be avoided solely because the medicine was manufactured by a separate entity.
Apart from the packaging-related issues, the FDA inspection reportedly uncovered several deficiencies in warehouse management. These included the absence of the mandatory Form 35 inspection book, inadequate storage infrastructure that resulted in medicines being kept directly on the floor, accumulation of dust on drug stocks and shortcomings in overall cleanliness and maintenance.
The regulator also observed that expired medicines were allegedly not stored in a separately designated area clearly marked as "Expiry-Not for Sale".
In addition, it cited the absence of prescribed standard operating procedures and records related to the disposal of expired drugs.
Source: IANS
About Gopi
Gopi Adusumilli is a Programmer. He is the editor of SocialNews.XYZ and President of AGK Fire Inc.
He enjoys designing websites, developing mobile applications and publishing news articles on current events from various authenticated news sources.
When it comes to writing he likes to write about current world politics and Indian Movies. His future plans include developing SocialNews.XYZ into a News website that has no bias or judgment towards any.
He can be reached at gopi@socialnews.xyz