In a severe blow to the companies selling drugs online to overseas clients without prescription and license, Maharashtra Food and Drug Administration (FDA) has approached the Drugs Controller General of India (DCGI) to device an action plan for completely stopping this clandestine activity. Stating it as a nationwide phenomena, an FDA official maintains that they are in constant touch with DCGI to plug the loophole in terms of enforcement of the drugs act before it culminates into an alarming situation.
FDA officials say this is a huge racket as foreign buyers can obtain prescription drugs including addictive anti-depressants, anti-hypertensives and those containing sildenafil citrate (a key component in drugs for erectile dysfunction also used to treat pulmonary arterial hypertension) easily and beat stringent rules in their local markets. Says a senior FDA official, "FDA has till date seized drugs worth over Rs. 2 crore from various parts of the city over the last one month and are still on the lookout for more companies involved the illegal sale of prescription drugs."
As per sources, more than 20 Indian companies are involved in the racket.
But FDA officials beg to differ and say, "We are yet to ascertain the magnanimity and quantum of the racket as distributors in India tie up with agents abroad after which the drugs are dispatched as per the order. Most of the drugs seized till date had invalid prescriptions. Our dialogue with DCGI is aimed at addressing this problem in totality on an urgent basis."
Online purchase of medicines is a clandestine activity and as Maharashtra FDA Commissioner pinpoints, "It is an unorganised trade and forms a miniscule part of the total Rs. 80,000 crore export business potential accounted from India. We are still investigating the matter and more such companies might face action for illegal sale of drugs without a license and prescription in contravention to Section 18 C and 18 (a) (6) and may attract penalties under Section 27 (b) and (d) ranging from 3 years imprisonment or fine upto Rs. 10, 000 or 5 years imprisonment or fine above Rs. one lakh.
Two Mumbai based companies had filed a petition last month at Bombay High Court 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.