The Maharashtra Food and Drug Administration (FDA) is in the process of canceling licenses of two Mumbai-based export companies for illegally selling addictives, anti- depressants and anti-hypertensive drugs to overseas clients in contravention of the Section 18 C of the Drugs and Cosmetics Act.
Action to be taken by the state regulator is the fallout of a recent Bombay High Court order disposing the case in response to a writ petition filed by the export companies. The companies had asked for a stay on FDA prohibiting online sale of medicines to overseas clients in violation of Section 18 C and Rules 65 (2), 65(3) and 65 (9) of D&C Act.
Says Sanjay Kale, joint vigilance commissioner, FDA, "We will be canceling the licenses of these companies as they have been found selling the drug without a retail license and secondly without a formal prescription from a registered medical practitioner."
The companies had filed a petition a month ago after FDA officials prohibited medicines like sildenafil citrate and other potent addictives, anti-depressants and antibiotics from being exported to foreign shores of UK, US, Japan, France and Russia wherein orders were placed by consumers over internet.
According to officials, FDA has seized and issued orders prohibiting drugs worth over Rs. 2 crore from 28 locations in the past three months from Nagpur, Mumbai and Pune alone. Says an FDA official, "Investigations are going on and have revealed that the illegal online trade of medicines spread to many parts of the country and over 20 such trading companies are under the FDA scanner for supplying drugs to clients overseas."
According to an FDA official, selling drugs online without a license may also attract penalties like imprisonment of not less than three years which can be extended upto five years or fine upto one lakh or three times the worth of seized drugs (whichever is more), under Section 27 (b) (2).
Besides this, selling without prescription can amounts to violation of preventive Sections 18 (a) (6) and 18 C and the offender can face imprisonment for not less than one year which can be extended upto two years or fine of not less than Rs. 20,000.
Drugs containing sildenafil citrate and tadalafil are used for treating erectile dysfunction and arterial hypertension. Globally, they are listed as prescription drugs and can be bought with a prescription of a qualified doctor of that country. An overdose of these drugs can lead to blood pressure shooting up, heart attack and eventually land a person in coma or death if consumed along with alcohol.
Investigations have also revealed that companies were selling sildenafil citrate to US, African and European based clients and that they had no buyers in the domestic market. Firms were dispensing the tablets via air courier without obtaining the drug license from FDA and export license from the assistant drug controller's office.