The small scale manufacturers are planning to file ‘contempt of court’ suits against state drug controllers and are planning to send either stop manufacturing or closure notices for not complying with the Schedule M norms citing a Calcutta High Court order, it is learnt.

The Confederation of Indian Pharmaceutical Industries (CIPI), the apex body of the state level pharmaceutical manufacturers associations, has already obtained legal opinion on this matter, according to Guptha, co-chairman and T S Jaishankar, chairman, CIPI. As reported earlier, the Calcutta High Court had granted a stay on implementing clauses related to large volume parenterals (LVPs) as part of the revised Schedule M, based on a petition from an association of LVP manufacturers in West Bengal.

According to the CIPI leaders, expert lawyers cite that the Calcutta High Court order is binding in the national scenario as the court has given a stay order on the Schedule M notification itself. The order has not specified whether the stay is restricted only for large volume parenterals (LVPs) manufacturers in West Bengal or LVP manufacturers in general. In this context, the order could be interpreted as a general stay order on Schedule M and notices could be interpreted as ‘contempt of court’ as per the rules.

It may be noted that the Drugs Controller General of India (DCGI) had told Pharmabiz that the Calcutta court order has validity in West Bengal alone and binding related to that category of specific petitioners only, and not in a national scenario.

“We are waiting for the legal opinion in writing from our senior lawyers who are studying the case. Once that is available, the copy of the Calcutta High Court order along with the legal opinion of the lawyers will be circulated to the notice-served members. They could individually respond to the notices of drug controllers with these letters, besides filling ‘contempt of court’ petitions in respective courts,” said Jaishankar.

It may be noted that CIPI was earlier planning to go the legal route to get a stay on Schedule M notification, but the lawyers consulted had discouraged the move stating it was a futile cause to challenge the government rule.

According to the CIPI leaders, closure of large number of SSI units are unlikely to happen as there is a renewed vigour among the manufacturers to comply with the rule, following the proposed move of the government to reduce the central excise duty from 16% to 8% and to increase the investment limit for SSIs.