The Calcutta High Court has granted a stay on implementing clauses related to large volume parenterals as part of the Revised Schedule M based on a petition filed by a local manufacturer, it is learnt.
The Court decision, just a few weeks before the deadline for implementing Schedule M, has come as a last ray of hope for numerous manufacturers and small-scale pharmaceutical associations from various states to approach Courts to get stay on implementation of Schedule M requirements.
Reacting to the development, Aswini Kumar, Drugs Controller General of India (DCGI) told Pharmabiz that the court order is unlikely to affect the mandate given to the non-complainant GMP units. “It is not an issue at all. Courts cannot pass judgment on technical matters like this and stay is not a verdict. I am yet to get a copy of the court order. If an association obtained a stay in that state, it will be restricted only to the jurisdiction of that state and if it is an individual manufacturer, it is restricted only to that manufacturer. As of now, all the manufacturers have to comply with the deadline,” said DCGI.
Meanwhile, the Confederation of Indian Pharmaceutical Industries (CIPI-ssi), the umbrella association of various state level SSI pharmaceutical associations, has already instructed its state level associations to seek legal opinion on approaching respective high courts to obtain a complete stay on Schedule M, in the wake of the Calcutta High court order. The Federation of South Indian Pharmaceutical Manufacturers Association (FOSIPMA), the joint association of pharmaceutical manufacturers in Kerala, Karnataka, Tamil Nadu, Andhra Pradesh and Pondicherry is also exploring options to approach the Madras High court to obtain a stay on revised Schedule M norms for formulators.
“Earlier, we were reluctant to approach the court hoping the government would consider our genuine reasons to offer more time to meet the requirements. In the wake of the Calcutta High Court order, I have instructed state level associations to study the court order and seek legal remedies from respective states. FOSIPMA is also planning to move Madras High Court for the formulation units in South India,” said TS Jaishankar, chairman, CIPI.
“We are in the process of getting a copy of the court order and have to study on what grounds the court awarded the stay. After consulting legal experts and fellow manufacturers, we are likely to immediately move the petition,” said B Sethuraman, president of FOSIPMA and Tamil Nadu Pharmaceutical Manufacturers Association.
Sources said about 25 parenteral units are located in the state of West Bengal. Industry association leaders from West Bengal said they were yet to identify the manufacturer who obtained the stay, and are in the processing tracing the court order.