In recent years, licensing and quality control for manufacturers and national regulatory authorities has become more complex. The National Institute of Biologicals (NIB) has been working since 1992 as an autonomous organization under the Ministry of Health and Family Welfare, Government of India, to strengthen the regulations on biologicals in India. The institute assures and reviews quality of biological products available through domestic manufacturers and importers. The operations are carried out in the state-of-the-art facility of the institute and in close co-ordination with government regulatory authorities, such as the office of Drug Controller General of India and the Indian Pharmacopeia Commission.

Indian companies are ramping up their facilities in adherence to quality standards for both the regulated and unregulated markets of the world, but they still have a long way to go. "One area that could be improved upon is the availability of more current good manufacturing practices (cGMP)-approved manufacturing facilities," says Mr Chinny Rao, executive director, Transgene Biotek. "This can sometimes sit alongside a dearth of knowledge concerning the exact standards and parameters prescribed by foreign regulators, and the absence of government support in dealing with or overcoming foreign government restrictions on imports. In commercial terms this just adds to delays in manufacturing time lines and also cost increases."

Quality is priority
Companies dealing in biologics say adhering to quality parameters is of utmost importance to them. Dr Esmail Samiwala, senior VP, USV, says USV's focus is to maintain the highest quality standards at all stages. "USV believes in the concept of one quality and one development for both regulated and semi-regulated markets. The EU and the US cGMP standards along with Indian GMP standards are strictly adhered to while manufacturing at both drug substance and drug product manufacturing plants," he says. The companies, as a part of their yearly training calendar, provide training to employees on-the-job to maintain quality standards. Updating employees about the regulatory requirements and ensuring that the new standards are implemented in a time-bound manner are regular practices at all manufacturing plants.

Mr Chinny Rao, says, "In addition to regular internal auditing of our facilities and processes, we also adhere to cGMP, ISO and EU guidelines as standard practice."

India's biggest vaccine manufacturers, such as Serum Institute of India in Pune, Panacea Biotec in New Delhi, and Bharat Biotech in Hyderabad, who manufacture a variety of biological products, follow quality parameters strictly. As a result of this, these firms have emerged as major exporters, matching international quality expectations. The quality audits have been part of the regular programs in order to ensure that overall quality concerns of the companies are addressed.