The government will amend rules for making provisions for obtaining approval by the sponsor or the manufacturer for making post-approval changes in respect of indications, dosage, dosage form and route of administration for biological drugs or vaccines.

Though these provisions had already been intimated to the stakeholders through the guidance document by the Central Drugs Standard Control Organisation (CDSCO), the health ministry will formally amend the Rule 122A and Rule 122B of the Drugs and Cosmetics Rules.

The step is taken following observation regarding this by the team of World Health Organisation (WHO) during their assessment in December 2012. The WHO team noted that there were no specific provisions under the Rules in respect of post-approval variations in the manufacturing process. Accordingly, the CDSCO brought out the guidance document with guidelines for making applications for post-approval changes in respect of quality, safety and efficacy.

The Drug Technical Advisory Board (DTAB), the highest advisory panel on technical matters under the union health ministry, has already given its approval to make the necessary amendment in accordance with the guidance document, it is learnt.

The post approval changes in respect of indications, dosage, dosage form and route of administrations are already covered under the definition of new drugs under Rule 122E. Now the Rules --122A and Rule 122B-- relating to application for permission to import new drug and application for approval to manufacture new drug will be amended.

“Subsequent to grant of permission for import/manufacture of vaccine or biological product as a new drug, changes in manufacturing process, manufacturing facility, site of manufacture, batch size, shelf life, presentation or any other change which might affect its identity, strength, quality, purity shall be submitted to the licensing authority as defined in clause (b) of Rule 21, duly supported by technical data for the purpose of approval. The fee to accompany such an application shall be fifteen thousand rupees,” according to the proposed change approved by the DTAB.