In a severe blow to the companies selling drugs online to overseas clients without prescription and a license, Maharashtra FDA will now initiate fresh legal action against two Mumbai-based companies for violation of the Drugs and Cosmetics Act. Such medicines are very expensive and not easily available without a prescription abroad and are purchased over internet from India in violation of Customs Act and Drugs and Cosmetics Act.

The new round of action to be initiated by the state regulator is the fallout of a Bombay High Court order disposing the case in response to a writ petition filed by pharmaceutical export companies - Fidelity Healthcare and Kayem Pharmaceuticals. The companies had asked for a stay on the crackdown by FDA for selling medicines overseas in contravention to Section 18 C and Rules 65 (2), 65(3) and 65 (9) of D&C Act.

Says Sanjay Kale, joint vigilance commissioner, FDA, "Now that the matter has been disposed of by the court, we will be taking action against these companies as they have been found violating the rules of Drugs and Cosmetics Act by selling the drug without a retail license and secondly without a formal prescription from a Registered Medical Practitioner as mandated by the Medical Council of India (MCI)."

The companies had filed the petition after FDA officials prohibited medicines like sildenafil citrate or Viagra and other potent addictive 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.

The HC has directed that final action be taken by FDA against the companies as per Rule 65 and other relevant sections of Drugs and Cosmetics Act. An NOC is required from the DCGI office for exports of such medicines to foreign shores.  

Online purchase of medicines is a clandestine activity and as per senior FDA officials, it is an unorganised trade and forms a miniscule part of the total Rs.80,000 crore export business potential accounted from India.