Maharashtra Food and Drug Administration (FDA) is planning to file prosecution against a Mumbai-based pharmaceutical firm for exporting paracetamol tablets overseas under its brand name in violation of Drugs and Cosmetics Act, 1940.

The firm was found re-branding and exporting drugs overseas originally manufactured by a Gujarat-based firm in violation of Section 18 (C) of the Drugs and Cosmetics Act, 1940.

According to an official associated with the development, “This is a unique case that we have detected probably for the first time in the recent past. We are still investigating the case. The accused used to sell paracetamol tablets in his own name manufactured by another company based in Gujarat.”

FDA intelligence officials revealed that they carried out a raid on the premises of the company and found that there was fudging of documents to mislead authorities that drugs were manufactured there.

State FDA officials found that the company was purchasing the medicines from a company in Gujarat and repackaged it to show as if they were being manufactured by a Mumbai firm, when they had actually outsourced them.

It was also found that the drugs were probably not tested which made it pose a potential health problem. The company also did not have loan licensing that allows part processing if a manufacturing units lacks certain facility or expertise.

Officials say this is a clandestine activity as foreign buyers can also 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.

As per the law of the land, such companies are liable to 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 up to Rs.10,000 or 5 years imprisonment or fine above Rs.one lakh.

Two Mumbai-based companies had also filed a petition at Bombay High Court (HC) in the past after FDA officials prohibited medicines like sildenafil citrate branded as 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 online.

The HC had directed that final action to be taken by Maharashtra FDA against the companies as per Rule 65 and other relevant sections of Drugs and Cosmetics Act, 1940.