Pharmacy Council of India (PCI) has chalked out an aggressive plan to create a pool of regulatory professionals with relevant skills. It is looking to introduce regulatory sciences as a specialization in M Pharm, PG diploma and also introduce a block teaching programme spanning six weeks of 10 hours each for training the faculty and the industry professionals.

Although JSS University four years ago commenced courses on regulatory sciences under its Knowledge Initiative Consortium , Dr. Suresh now sees it necessary to drive the future of the industry. “If innovation is the goal , then regulatory sciences is the way forward,” he said in his address at the IPA Platinum jubilee event for the Dr. Venkateswarlu Memorial Lecture on the topic ‘Innovations to Meet Challenges to Achieve Excellence in Regulatory Compliance.'

Regulatory sciences is vital for India when there has been a slew of eight warning Letters, since 2013 to Indian companies alleging improper data controls. FDA has also sent several Form 483s, the precursor to most Warning Letters, to Indian companies such as one to Ranbaxy in January 2014. These letters stick out because unlike manufacturing deficiencies, data integrity issues strike at the very core of good regulation, he noted.

Indian pharma industry will now need to attract dedicated team of professionals qualified in the regulatory sciences. This is the key to keep pace with changes in the global regulations and the certify as a quality manufacturer during the international audits that are currently being undertaken. “Now intend to integrate regulatory sciences in the pharmacy colleges and promote it as a profession of the future,” Dr Suresh told Pharmabiz at the sidelines of the event.

“In the next three months we intend to introduce a series of regulatory science programmes across the colleges in the country. This would be a one year course with 10 modules before it takes of as M Pharma. This will support the regulatory departments in the government and industry to have access to trained manpower,” he said.

Union government will need to mandate presence of regulatory sciences qualified and trained personnel to put in place futuristic polices to strengthen the regulatory framework and related infrastructure to keep pace with the international audits taking place across pharma companies in India, said Dr. Suresh.

The Council is also viewing options of triangular partnership with the regulatory authorities, industry and academia with an objective of creating trained professionals and create a high standard talent and capability in regulation.

Much of the warning letters have come in from the international regulators because of eight causes of non-compliance from the point of view of those who fail to understand the law, collapse of belief in law, procedural injustice, costs of regulatory compliance, deterrence failure, incapacitation of those regulated and failure of persuasion and the civil society, he pointed out.

The only way out is to adopt regulatory sciences and put in place systems and a sound policy, said Dr Suresh.