Clampdown on illegal export of drugs from Maharashtra to foreign countries by the state Food and Drugs Administration (FDA) has been lauded by the Centre. The ministry of commerce in Delhi has extended its support to Maharashtra FDA in an official letter and asked for such enforcement action to be replicated across other states in India.
Over the past four months, FDA officials have prohibited or seized drugs, including sex boosters Sildenafil Citrate and Viagra, heavy antibiotics and anti-depressants worth nearly Rs3.2 crore by raiding premises of 49 drug exporters across the state as also foreign post office in Ballard Estate, South Mumbai, international airports and private courier firms. The medicines are ordered via websites without valid prescriptions in the US, Europe, Africa and Russia, among other countries, in violation of the Customs Act and Drugs and Cosmetics Act, 1940.
In the letter dated May 19 to Drugs Controller General of India (DCGI), the ministry has said illegal export of drugs has a huge potential to damage the credibility of Indian pharma exports. It also reinforced the fact that the ministry had been harping on about strong measures that ought to be taken by regulatory authorities to maintain credibility in the market. The ministry has said DCGI should ask FDA of all states to follow the Maharashtra model and evolve an action plan to counter illegal sale of prescription and addictive drugs over the internet.
India officially exports drugs worth over Rs70,000 crore to several countries. FDA officials said the illegal exports constitute a small fraction of the cost. However, no statistics of the extent of the illegal trade are available.
"The illegal activities impact the official Indian trade channels. Trust of importing countries in India will not stay robust if there is an influx of possibly substandard or counterfeit Indian medicines in foreign market," said a ministry official.
FDA officials said concerted efforts by DCGI, Directorate General of Foreign Trade, customs department, Directorate of Revenue Intelligence and postal department were required to nip the problem in the bud.
"Every department has a stake in passing on drug consignments to foreign countries without proper checks. Illegal operations controlled by underworld are spinning huge financial gains," an FDA official told dna.
The ministry has indicated that on the basis of Bombay high court's ruling on March 18, 2014, which refuses to grant relief to exporters, regulatory authorities in the country should be sensitised.
Illegal export of medicines is a countrywide concern and state FDA has asked for the probe to be shifted to the Central Bureau of Investigation (CBI). "We have written to the DCGI and ministry of commerce asking for in-depth investigations to be undertaken by CBI," said Mahesh Zagade, state FDA commissioner.
Maharashtra FDA is one among the many law enforcement agencies spread across 100 countries involved in an international crackdown. The sustained crackdown, Operation Pangea, is a seven-year-old campaign led by international watchdog Interpol to shut illegal internet pharmacy businesses. Till date, Interpol has seized drugs worth $43 million, closed multiple websites and arrested 39 people involved.