Alleged Sale of Schedule H and H1 Medicines Without Prescription; FDA Complaint Against 30 Medical Stores in Mumbai and Pune

Dr. Vedprakash Tiwari

A complaint has been filed with the Food and Drug Administration (FDA) against a total of 30 medical stores in Mumbai and Pune, alleging the sale of Schedule H and H1 medicines without a valid prescription issued by a Registered Medical Practitioner (RMP).

Dr. Vedprakash Tiwari, Advocate Bombay High Court, has submitted the complaints in the public interest, seeking immediate investigation into the alleged violations. Photocopies of the bills/invoices relating to the medicines purchased from the concerned medical stores have also been enclosed with the complaints as documentary evidence.

18 Medical Stores in Mumbai Named in the Complaint

The Mumbai complaint names Apollo Pharmacy – Runwal Avenue, Generico Plus, Janata Medical & General Stores, R. Parmesh & Co. Chemist & Druggist, Wellness Forever Chemists & Lifestyle Store, New Matoshree Medical, Wellness Forever Chemists & Lifestyle Store (Vikhroli), Pills & More Chemist & Druggist, Citi Care Pharma, Zeno Health (Zippin Pharma Pvt. Ltd.), Medicine Life Pharmacy, Honeybell Pharma Pvt. Ltd., Bhatia Medical & Super Markets (LLP), Bhatia Medical & Super Market, various branches of Bhatia Medical & Supermarket LLP, Medico Point and Milan Medical & General Stores.

According to the complaint, some of the bills relating to the transactions allegedly do not bear the signature of the registered pharmacist. The complainant has therefore sought verification of whether a registered pharmacist was actually present at the respective establishments at the time of sale.

12 Medical Stores in Wagholi Also Under Complaint

A separate complaint has also been submitted to the Joint Commissioner, FDA Pune Division, against 12 medical stores operating in the Wagholi area of Pune district.

The establishments named are Wellwise Medical, New Vighnaharta Medico & General Stores, Vijay Medico Chemist, Druggist & General Stores, Darshan Medico, Sanjivan Medical & General Stores, Darshan Medico – Branch No. 2, Prisha Medico & General Stores, Pharma N More, Shrisha Medicare, 24/7 Medicine & More, Health & Happiness and Anytime Pharmacy Chemist & Druggist.

Copies of the relevant invoices have also been enclosed with the Wagholi complaint. The complaint specifically claims that the relevant invoices issued by Darshan Medico – Branch No. 2 and Prisha Medico & General Stores do not bear the signature of the registered pharmacist.

Medicines Purchased in the Name of Ganesh Rokade

According to the complaint, the medicines from the Wagholi establishments were sought in the name of ‘Ganesh Rokade’. The complainant has clarified that the medicines were not purchased for treatment purposes, but solely as part of a public-interest exercise to ascertain whether Schedule H and H1 medicines were being dispensed without a valid prescription and to document any such alleged irregularities.

The complainant has stated that the exercise was intended not to harass or target any individual, but to bring to light any violation of drug-sale regulations that could potentially endanger public health.

Demand for Verification of CCTV and Sales Records

In the Mumbai complaint, the FDA has been requested to verify the CCTV footage, sales records, purchase records, prescription records and invoices/cash memos relating to the transactions in question.

The complainant has also sought verification as to whether a valid prescription issued by a Registered Medical Practitioner was produced at the time of sale and whether the required statutory records were properly maintained.

Serious Public Health Concern

The complaint describes the alleged sale of antibiotics and other prescription medicines without medical supervision as a serious public health concern, stating that such practices may encourage irrational use of medicines, self-medication and antimicrobial resistance (AMR), besides increasing the risk of adverse drug reactions.

Demand for Special Inspection Drive

The complainant has requested the FDA to conduct a special inspection drive covering medical stores in Mumbai and Pune to verify compliance relating to the sale of Schedule H and H1 medicines.

The complaints also seek appropriate legal and administrative action under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945 if violations are established, including appropriate action against the licences of erring establishments wherever warranted.

The complainant has further sought that all licensed pharmacies be directed to strictly comply with the applicable statutory requirements.

However, whether the concerned medical stores have actually violated the applicable provisions will be established only after an official inspection and investigation by the FDA. The action taken by the FDA on these complaints and the findings of the proposed investigation are now being closely watched.

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