According to the CMDh practical guidance for Marketing Authorization Holders (MAHs) of nationally authorized products, the evaluation of nitrosamine impurity or cross-contamination in a marketed product is a critical criterion. Nitrosamines are proven to be carcinogenic and can affect the overall output of the formulated product.

Considering the severity, the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) issued the following first three (03) steps a manufacturer must follow to mitigate the amount of impurity in the final drug product.

Advance Therapy Medicinal Products (ATMPs) are novel drugs that meet patients’ specific needs. But they drastically increase the cost of treatment. Generic alternatives provide relief in terms of treatment cost with a quality drug of similar effectiveness.

The chemical industry has played a pivotal role in boosting the Indian economy and providing livelihood to more than two (02) million people. As the Indian Government intends to transform India into a global manufacturing hub for chemicals, the industry is set to witness major positive shifts. India, indeed, has become a key investment destination for chemical manufacturers.