Indian Pharmaceutical Alliance To Set Up Global Academies In Ahmedabad, Hyderabad

The Indian Pharmaceutical Alliance is exploring a collaboration with global pharmaceutical associations—the Parenteral Drugs Association and the International Society for Pharmaceutical Engineering—to set up the Pharma Academy for Global Excellence in Ahmedabad and Hyderabad to encourage skill training across levels in India's pharmaceutical sector.

The collaboration is in the early stages of foundation to provide focused training on digitisation, aseptics, oral solids, drug quality and artificial intelligence, according to IPA members.

"We will buy the land very soon, and the construction of PAGE will start in the next 12–18 months. Meanwhile, we will start working on the course," Sudarshan Jain, secretary general of the Indian Pharmaceutical Alliance, told NDTV Profit on the sidelines of the inauguration of the 9th Global Pharmaceutical Quality Summit.

The move comes as good manufacturing practices and healthy drug quality are being emphasised amid an increase in the number of inspections by regulatory bodies. Further, increasing demand for drugs and biosimilars, active pharmaceutical ingredients, and the advent of artificial intelligence and other intricate technologies has made education and skill training important.

"Ensuring good manufacturing practices is now a priority over pricing," said Jain. Prices of pharma drugs are about 65% lower in India than in other big countries, Jain said, citing a study by IPA. Hence, the body has dealt with the pricing already, according to him. However, IPA is planning to improve its partnership and supply chain with the US to make drugs more affordable in both nations.

Despite the increase in the number of quality inspections, there has been a substantial drop in the percentage of inspections on which official action has been indicated by the US Food and Drug Administration over the past decade, according to IPA data.

The overall percentage of OAIs on Indian pharmaceutical companies had halved to 13% in 2023 from 26% in 2014. Although gaps in practices, maintenance of facilities and ancillaries, and investigations not being done versus the written procedures have risen to 23%, there is a drop of 3–4% seen in violations found in capability, training, lab controls and core manufacturing processes.

When asked what the IPA expects from the upcoming budget in July, Jain said some "flip" around innovation is likely this time, which is also what the body demands the most. It is optimistic about other underwhelmed areas, such as nutraceutical drugs and bioanalytical services, where significant development is expected going forward.

"We have formed a committee to look into aspects related to nutraceuticals," said Jain. Nutraceuticals refer to compounds or food products that are expected to have clinical benefits but may or may not be scientifically proven.

Although manufacturing of nutraceuticals should be encouraged in India, mixing of drugs should be checked to avoid cross-contamination, Jain said. "Regulators need to make sure that permission for nutraceuticals should be given only if there are no chances of mixing with other drugs."

Further, there is still no clarity over who will look into the regulation of nutraceuticals, Jain said. It remains to be seen if it will be the Food Safety and Standards Authority of India or the Central Drugs Standard Control Organisation.