Following the recent DCGI circular to the state drug regulators to keep a check on online firms selling prescription medicines, Maharashtra Food and Drug Administration (FDA) detected a unique case of online sale of prescription drugs to overseas clients by a Mumbai based firm in contravention to the rules of Drugs and Cosmetics Act.
Officers of the FDA vigilance team and BMC officers raided the premises of the Mumbai based online firm, Vbuzz Teleservices Pvt Ltd, and found a team of 70 to 80 agents selling the prescription drugs online without wholesale and retail licenses.
The online firm used to sell prescription drugs meant for hypertension and also drugs like sildenafil, vardenafil and tadalafil to overseas clients in Germany, Canada, Australia and the US without a license in contravention to Section 18 (a) and 22 (1) of D&C Act, 1940.
These drugs which can only be prescribed by a dermatologist, psychiatrist, urologist and endocrinologist used to be sold in the strips of 30, 60, 90, 100 and 200 with the seller or online agent given the target of selling drugs worth 200 USD at one time.
According to an FDA official, the irrational usage of these drugs could lead to sudden vision loss, ringing in ears or sudden hearing loss, chest pain, nausea, irregular heart beat, swelling in hands, ankles or feet, shortness of breath, vision change also leads to reduction in cardiac output which can be detrimental in cardiac patient. It can increases risk of bleeding in patients with bleeding interactions disorder.
A committee was also constituted by the Drug Controller General of India (DCGI) as a part of 48th Drug Consultative Committee (DCC) meet in Delhi to frame regulations on online pharmacy in the country, which held its first meeting in September last year under the chairmanship of Maharashtra FDA Commissioner Dr Harshdeep Kamble.
The meet was a significant move as drug being an important segment in the e-commerce space, information technology advancements will help gain access to medicines in a timely manner. Recommendations on the same sought from all the state drug controllers were reviewed during the meet.
Two types of online pharmacy models exist now wherein the patients get the medicine based on an indicative prescription sent online to the retail drug store so that necessary stock of prescription drug is made available to the patient timely with pharmacist authorised bill and stamp. Second type of model sell prescription drugs online without a prescription based on the patient's demand via a post or courier delivery.
As per 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.