Maharashtra Food and Drug Administration (FDA) has issued notices related to suspensions of licenses to over 200 drug retailers in the state for professional misconduct and other violations like improper maintenance of records. This crackdown according to the state FDA chief Harshdeep Kamble has led to subsequent reduction in cases of non-compliance. "Earlier over 500 cases of non-compliance used to be detected like absence of pharmacists and non-maintenance of records among other major irregularities. We have registered 50% reduction in non-compliance in the state over the past couple of months," Dr Kamble said.
As a follow-up of show cause notices issued by FDA to 4503 medical stores across the state between April 2014 and February 2015, the state regulator had canceled 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.
The FDA's crackdown is meant to curb the menace of irrational usage of antibiotics and cancellation of licenses is done based on the non-compliance like dispensing medicines without prescription in the absence of pharmacist and non-compliance to schedule H. The Union health ministry had also introduced Schedule H1 to regulate the use of antibiotics in the country, and had placed 46 antibiotics under this category.
Taking forward the compliance to Schedule H and Schedule H1, Maharashtra FDA had 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 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 and 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 per the Section 18 (c) of Drugs and Cosmetics Act, 1940 to be read with Rule 65, only a licensed retailer is entitled for the sale of drugs and that too on the basis of prescription of a doctor only. Rule 65 prescribes the procedure to be adopted by the medical stores while selling the prescription drugs and under which the prescription from the registered medical practitioner is necessary for sale of Schedule H drugs under the Act.
The Maharashtra FDA 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 violation of D&C Act. During the year, the FDA had conducted inspections on 48,086 retail stores in the state.
Similar kind of actions were also taken by FDA under the Drugs and Magic Remedies (Objectionable Advertisement) Act (DMR Act). FDA had served 1434 notices and filed 58 FIRs last year.