Bengaluru: Union government has now formed a committee to examine the matter of manufacturing of nutraceuticals within the drug manufacturing facility. This follows the implementation of revised Schedule M mandating dedicated areas for manufacture of nutraceuticals and pharmaceuticals.
In this regard a committee has been constituted comprising A Visala, Joint Drugs Controller (I) CDSCO, Ranga Chandrashekar, Joint drugs controller CDSCO (HQ), AK Pradhan, advisor, CDSCO, (HQ), Arvind Kumar Bansal, NIPER, Mohali and SM Mudda, industry expert.
The communication from the government has stated that enforcement division of the CDSCO (HQ) will provide the secretariat assistance to the committee. The committee will submit their report within a period of three weeks. All the members of the committee will need to adhere to the principles of confidentiality.
India is the pharmacy of the world, said industry sources and went on to state that so far multivitamins and minerals have been manufactured in the same facility that produces medicines. Globally, both nutraceuticals and pharmaceuticals are manufactured at the same facility. The formation of committee is a step in the right direction and needs to be looked into.
Now manufacturers are engaged in the production of nutraceuticals and pharmaceuticals in the same unit. This is going to be recurring investments. While this integration may be beneficial in terms of operational efficiency or product diversification, but it will also create pressure on expenses for the industry. This pressure could stem from various factors such as additional regulatory requirements, specialized equipment needs, or increased research and development costs to ensure compliance and quality in both product lines, noted the industry.
Noting that there have been significant discussions regarding permitting the manufacturing of nutraceuticals within same unit of pharmaceuticals in India, Sanjaya Mariwala, executive chairman and managing director, OmniActive Health Technologies and president of the Association of Herbal and Nutraceutical Manufacturers of India, said that segregating production lines to meet stricter quality standards is a welcome thought, but it will be expensive and can cause supply chain disruptions and reduced exports.
In light of this ongoing development, our view is that a high-standard pharmaceutical plant should be allowed to make nutraceutical products. We see there is no harm in it. Perhaps the opposite may not be acceptable, that is a nutraceutical plant manufacturing pharmaceuticals. Here, a more collaborative approach between regulators and manufacturers is needed, he added.
Understanding industry hurdles and offering incentives are crucial steps. Both sides should strive for rigorous quality control, premarket reviews with clinical trials and accurate labelling to guarantee product integrity. Non-compliance must be met with penalties, pointed out Mariwala.
In addition, a unified regulatory body would streamline processes and inject much-needed order into unethical and flawed practices. This comprehensive strategy would foster a competitive, compliant industry primed for sustainable growth and global leadership, said Mariwala.
