SC overturns govt drug ban, allows sale of three FDCs
TIMES NEWS NETWORK
New Delhi:18.09.2018
The Supreme Court on Monday allowed sale of Saridon, Piriton Expectorant and Dart — three fixed dose combination (FDCs) drugs — recently been banned by the Centre along with 325 other drugs and permitted pharmaceutical companies to manufacture and sell the medicines.
Agreeing to hear the plea of pharma majors which approached the apex court challenging the Centre’s decision to ban the drugs, a bench of Justices R F Nariman and Indu Malhotra issued notice to the Centre and stayed the government decision with regard to the three drugs.
The government took the decision on the basis of recommendation of a panel constituted by the Centre on the SC’s direction to review safety, efficacy and therapeutic justification of FDC drugs. Hearing a batch of petitions challenging the Centre’s 2015 ban on some FDC drugs, the court in December referred the issue to the Drugs Technical Advisory Board (DTAB) for a fresh view before recommending any action. FDCs are combinations of two or more drugs in a single dosage.
The review was ordered after the Centre challenged the Delhi high court order quashing its March 10, 2016, notification banning 344 FDC drugs citing health risks and lack of therapeutic justification. The ban on FDC drugs was enforced following a report by a six-member committee headed by Chandrakant Kokate, which in January 2015 termed 963 FDCs “irrational”, posing health threats. The court, however, said its Monday order will be applicable to FDCs given licence prior to 1988.
A sub-committee of DTAB submitted its report on 349 FDC drugs saying there is no therapeutic justification for ingredients in 328 FDCs and these can be a risk to people. The board recommended banning these drugs and the health ministry prohibited their manufacture, sale and distribution with immediate effect and restricted another
six. Challenging the Centre’s decision, manufacturing companies — Piramal Healthcare, GlaxoSmith-Kline and Juggat Pharma — filed an application before the court saying the order is illegal and arbitrary. Senior advocates Mukul Rohatgi and Shyam Divan contended the three FDCs were given licence before 1988 and the panel was not allowed to examine their safety and efficacy as per the court order.
Additional solicitor general Pinky Anand, appearing for the Centre, contested the arguments of the companies that drugs were given licence before 1988 and told the bench she would file response on behalf of the government.
Recording the statement of the companies, the bench allowed them to continue to manufacture the drugs and asked the Centre to file response.
AVAILABLE AGAIN:Saridon, Piriton Expectorant and Dart were banned along with 325 other drugs
TIMES NEWS NETWORK
New Delhi:18.09.2018
The Supreme Court on Monday allowed sale of Saridon, Piriton Expectorant and Dart — three fixed dose combination (FDCs) drugs — recently been banned by the Centre along with 325 other drugs and permitted pharmaceutical companies to manufacture and sell the medicines.
Agreeing to hear the plea of pharma majors which approached the apex court challenging the Centre’s decision to ban the drugs, a bench of Justices R F Nariman and Indu Malhotra issued notice to the Centre and stayed the government decision with regard to the three drugs.
The government took the decision on the basis of recommendation of a panel constituted by the Centre on the SC’s direction to review safety, efficacy and therapeutic justification of FDC drugs. Hearing a batch of petitions challenging the Centre’s 2015 ban on some FDC drugs, the court in December referred the issue to the Drugs Technical Advisory Board (DTAB) for a fresh view before recommending any action. FDCs are combinations of two or more drugs in a single dosage.
The review was ordered after the Centre challenged the Delhi high court order quashing its March 10, 2016, notification banning 344 FDC drugs citing health risks and lack of therapeutic justification. The ban on FDC drugs was enforced following a report by a six-member committee headed by Chandrakant Kokate, which in January 2015 termed 963 FDCs “irrational”, posing health threats. The court, however, said its Monday order will be applicable to FDCs given licence prior to 1988.
A sub-committee of DTAB submitted its report on 349 FDC drugs saying there is no therapeutic justification for ingredients in 328 FDCs and these can be a risk to people. The board recommended banning these drugs and the health ministry prohibited their manufacture, sale and distribution with immediate effect and restricted another
six. Challenging the Centre’s decision, manufacturing companies — Piramal Healthcare, GlaxoSmith-Kline and Juggat Pharma — filed an application before the court saying the order is illegal and arbitrary. Senior advocates Mukul Rohatgi and Shyam Divan contended the three FDCs were given licence before 1988 and the panel was not allowed to examine their safety and efficacy as per the court order.
Additional solicitor general Pinky Anand, appearing for the Centre, contested the arguments of the companies that drugs were given licence before 1988 and told the bench she would file response on behalf of the government.
Recording the statement of the companies, the bench allowed them to continue to manufacture the drugs and asked the Centre to file response.
AVAILABLE AGAIN:Saridon, Piriton Expectorant and Dart were banned along with 325 other drugs
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