The Supreme Court has asked the country’s technical advisory body on drugs to decide on the fate of more than 300 combination medicines banned by the government between March 2016 and June 2017. The order is a potential relief to drug makers who have argued that the government did not consult statutory bodies provided for in the country’s drug regulations before banning these drugs.
Companies can make and sell the 349 contested fixed dose combination drugs (FDCs) while Drugs Technical Advisory Board (DTAB) deliberates on the issue.
At the same time, the court also clarified that this order is specific to two of the government’s ban notifications due to “peculiar facts” of the cases.
In an order dictated in open court on two government notifications banning these FDCs, a Supreme Court bench of Justices Rohinton Fali Nariman and Sanjay Kishan Kaul on Thursday said it was setting aside the ban on 15 such drugs which were manufactured in India before 1988.
However, if it chooses to, the government can carry out further inquiry on whether these drugs should continue to be marketed in the country, the court suggested.
For the remaining 334 FDCs, the court suggested that DTAB should decide whether the manufacture and sale of these drugs should be regulated, restricted or outright banned, and submit a report with its recommendations to the government within six months.
FDCs are cocktail drugs that contain two or more therapeutic ingredients packed in a single dose.
While 344 of the contested drugs are currently available in the market as the Delhi High Court in December last quashed the ban on them imposed in March last year, the other five FDCs banned in June, too, can now return to the market.
The Supreme Court bench said DTAB or a sub-committee it sets up should hear arguments by the drug industry as well as patient group All India Drug Action Network (AIDAN), which is in favour of the ban notifications, before preparing its report.
The government is expected to carefully consider this report, “apply its mind” and accordingly either maintain or modify its ban notifications, according to it.
The Kokate committee — the government’s expert committee that had studied the FDCs and declared them “irrational” — was not clear as to the reasoning behind its decision, it observed.
The top court last month said the government does not have to consult statutory bodies like DTAB before banning FDCs as such consultations were not specified in Section 26A of the Drugs and Cosmetics Act. The government had used Section 26A, which defines its power to regulate the manufacture and sale of drugs “in public interest”, to ban these drugs last year on a separate expert committee’s recommendation.
“The judgment means that the government need not mandatorily consult DTAB to prohibit the manufacture and sale of FDCs it finds irrational and can use expert committees like the Kokate committee,” said S Srinivasan, a member of AIDAN. “Earlier, the Delhi High Court had quashed the ban only on the reasoning that DTAB was not consulted, but now the government has been empowered to act fast,” he said. “The only drawback is that six months seems too short a deadline to achieve all this,” he added.
AIDAN’s counsel Colin Gonsalves told the court on Thursday that there are 40,000 contested and debated FDCs in India, while any well-regulated country allows 500 FDCs at most.
Lawyers representing drug makers said the decision is a victory for the industry.
“The court has referred the matter for a fresh look to decide if the drugs require to be banned under Section 26A of the Drugs & Cosmetics Act,” said Ashish Prasad, partner at Economic Laws Practice, who represented Indian Drug Manufacturers Association (IDMA), Federation of Pharma Entrepreneurs (FOPE) and Confederation of Indian Pharmaceutical Industries (CIPI) during the proceedings.
Archana Sahadeva, associate partner at Singh & Singh Law Firm, who represented drug makers such as Cipla, MacLeods, Alembic and Microlabs, said, “This means that the process will now be more transparent.”
The 300 plus contested drugs include popular brands such as Corex, Phensedyl, D’Cold Total, Vicks Action 500 Extra and Saridon.
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