The Supreme Court has dismissed a petition filed by the Madhya Pradesh government, which sought to prosecute drug maker Smithkline Beecham Asia for allegedly manufacturing and selling spurious crocin syrup.
The Madhya Pradesh high court had earlier upheld a city court's decision to dismiss the state government's plea against the pharmaceutical firm.
The petition filed in the apex court through counsel C D Singh stated that the High Court had failed to appreciate that the presence of foreign element in the medicine was a clear breach of provisions of the Durgs & Cosmetic Rules 1945.
The rules provide that patent and proprietary of medicine should comply with general requirements, which include compliance with colour consistency, clarity and stability, freedom from contamination with foreign matter or fungal growth etc, the state added.
The petition was dismissed by a Supreme Court bench headed by Justice A K Mathur.
A drug inspector in October 1998 after inspecting the premises of a retail drug store in Alirajpur had found a black coloured suspended article in one of the sealed bottles of crocin syrup.
The drug inspector, Bangalore, after investigation had opined that there was a possibility of human error during manufacturing and packaging of the consummated crocin bottle manufactured in June 1998 and having expiry date of May 2001.
However, the Controller, Food and Drug Administration, Bhopal had given an approval to prosecute the company and its distributors for manufacturing and selling spurious and sub-standard drug under Drug Control Act, 1940.
The city court, on a petition filed by the pharma gaint, had quashed the complaint on the ground that Smithkline was not given an opportunity for chemical analysis of the consummated drug so as to contradict the drug inspector's report that was in a clear violation of Section 25(2)and (3) of the 1940 Act.
