The Confederation of Indian Pharmaceutical Industry (CIPI-ssi) is planning 'contempt of court' action against state drug controllers who dare to issue closure notices related to Schedule M.
CIPI, the umbrella organisation of SSI pharma organisations in the country, has also decided to send letters to the Drugs Controller General of India (DCGI) and the state drugs control administrations all over the country to stop further action against non-compliant pharmaceutical companies. Interestingly, the association had taken a same decision during October, last year, but did not pursue it further due to various reasons.
The newfound vigour of the SSI association comes in the wake of an expert legal opinion provided by a senior lawyer from the Delhi High Court, which was discussed at the two day national executive committee meeting held in Chennai, last week. The lawyer has informed the association that the order of the Calcutta High Court related to Schedule M is binding for all units in the country. The meeting has also formed a three-member committee exclusively to take care of the Schedule M implementation related issues. J R Agarwal, Vice Chairman, Umesh Sanghvi, Secretary General and Parthasaraty, Executive Committee member of CIPI, are the members of the committee.
"We are not against implementation of Schedule M and we have communicated our members to implement the rule at the earliest. Now about 1000 units are yet to comply with the rule and they are in various stages of implementing the same. We will include a letter-in-writing consisting legal opinion on the Calcutta High Court, which is applicable for the whole country as the case is against a nationwide policy," said T S Jaisankar, Chairman, CIPI (ssi).
It may be noted the DCGI had maintained the Calcutta High Court order is applicable only to the units in that state and for the members of the association which went to court. 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, 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.