In order to enhance enforcement for compliance of norms amongst retailers, wholesalers and manufacturers of pharmaceutical products, the Maharashtra Food and Drug Administration (FDA) conducted 122 raids in the year 2013-14 as compared to only 49 in the year 2012-13. The raids revealed rampant violations of Drugs and Cosmetics Act, 1940 and Rules, 1945 as offenders stocked drugs without license and sold them without purchase bills.
Maharashtra FDA also cancelled licenses of 2,241 retail pharmacies and suspended licenses of another 1,857 retailers across the state for violation of Drugs & Cosmetics Act like dispensing medicines without prescription.
This is the follow-up of show cause notices issued by FDA to 4503 medical stores across the state between April 2014 and February 2015. During the year, the FDA had conducted inspections on 24,193 retail stores across the state.
The FDA's crackdown is in line with the fact that there is irrational usage of antibiotics and cancellation of licenses is done based on the non-compliance like dispensing medicines without prescription. This comes as a welcome change more so as cases of online sales of prescription drugs have come to light with the growing trends of self medication especially in in tier -1 cities across the country.
The Union health ministry had also amended the D&C Rules to insert Schedule H1 to regulate the use of antibiotics in the country, and had placed 46 antibiotics under this category.
Maharashtra FDA recently raided an e-commerce site Snapdeal’s office and subsequently filed FIR against the company’s directors at the Panvel police station in Raigad district for online sale of prescription drugs. The state regulator has also written to the Drug Controller General of India (DCGI) to take further action in the interest of patient safety.
The company was found contravening provisions of the D&C Act and the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. The offences under which the FIR have been registered are cognizable and non-bailable.
The drugs included sildenafil citrate tablets, which are to be sold on prescription by urologists, psychiatrists, endocrinologists and dermatologists and also emergency contraceptives i-pill and Unwanted-72. Indiscriminate use of such drugs might lead to harmful effects.
As a part of FDA's crackdown to discourage irrational usage of of antibiotics, it had cancelled licenses of 5,452 retail pharmacies and suspended licenses of another 3,178 retailers across the state in the year 2013-14 for violations like dispensing medicines without prescription and without proper bill. During the year, the FDA had conducted inspections on 48,086 retail stores in the state.
During the year, the FDA had inspected 5,469 retail stores in Greater Mumbai, 7,143 in Konkan, 11,801 in Pune, 6,855 in Nashik, 4574 in Nagpur, 8097 in Aurangabad and 4,147 in Amravati FDA divisions. Around 901 licenses were cancelled and 693 suspended in Greater Mumbai alone. Maximum number of 1,384 cancellations were done in the Konkan division followed by Mumbai, Pune with 896 licenses, Aurangabad with 801, Nashik with 612, Amravati with 489 and Nagpur with 369.