The Madras High Court has upheld packaging norms introduced by the government in 2011 for curbing the export of counterfeit pharmaceutical products and medical devices.

The court agreed with the Centre’s stand that these were necessary to protect the country’s trade reputation.

The Directorate-General of Foreign Trade issued notifications in January and June 2011 with regard to primary, secondary and tertiary levels of packaging of pharmaceutical products meant for export to foreign countries.

In his order dismissing two petitions, which challenged a notification of June 30 modifying the notification dated January 1, 2011 and sought their quashing, Justice K. Venkataraman agreed with Additional Solicitor-General of India, P. Wilson, that the Centre thought it fit to impose certain conditions on the export of drugs and medicines in furtherance of the country’s trade reputation.

Industry contention

The Confederation of Indian Pharmaceutical Industry (SSI) and the Indian Drugs Manufacturers’ Association filed the writ petitions. The confederation, among other things, said that the notification would increase the cost of production. This would have to be thrust upon the foreign buyers, who may, due to higher price, opt out of purchasing Indian products and switch to countries such as China. The confederation members, who were registered small scale industries, would incur heavy loss because of the plant and machinery for the new packing line as per the GSI standard.

Mr. Justice Venkataraman said that in the minutes of the meeting of the Commerce Secretary of June 2010 regarding the strategy to contain the campaign against fake drugs, it was notified that a concerted campaign against Indian pharma industry had been launched by MNCs whose interests were getting adversely impacted due to the increasing global presence of Indian pharma companies, especially in the generic segment.

It was also been notified that news was appearing in the international press to malign the growing Indian generic drugs by labelling them as fake.

It was felt that there could not be any laxity in enforcement as that also harmed the domestic industry’s interest and domestic consumers. The Judge noted that in the counter, it was stated that to protect Indian medicines in the international market and to fulfil the manufacturers’ obligations, the Centre had issued public notice imposing certain conditions. When such was the government’s motto, the court could not sit over the government’s decision.

The petitioners had not established that the government’s decision and the public notice were arbitrary or a colourable exercise of power, Mr. Justice Venkataraman said.