There may soon be uniform regulatory standards for manufacturing units of the pharmaceuticals industry in the country as the government gets ready to join the Pharmaceutical Inspection Cooperation Scheme (PICS). The government is trying to implement a uniform inspection standard, calling it the Indian Good Manufacturing Practices (GMP). The PICS is an international instrument meant to improve cooperation in GMPs between countries and regulatory authorities. About 7000-odd small and large pharma manufacturing units, about 80 percent of the industry, in India do not follow World Health Organization (WHO) GMPs. These would find it difficult to comply with Indian GMPs as well. Sources in the government and the industry said this could lead to consolidation among smaller units. The government is also mooting a cooperative manufacturing model for small units.
The government wants that in a cluster where one small unit is making tablets, capsules, and syrups, it can concentrate on one and improve its manufacturing processes or standards. “One unit will only make tablets; another will make only capsules. They can, in turn, share their customers, or have a cooperative model,” said the source, adding that such arrangements are already operational in Gujarat. “There have been several meetings with representatives from pharma associations such as the Indian Drug Manufacturers Association (IDMA) and Bulk Drug Manufacturers Association (BDMA) and the drug regulator. It has been decided that a central consultancy agency or body would be formed that would advise the smaller units to upgrade,” said a source. The government has no plans to provide funds for this.
The drug regulator is of the opinion that there cannot be dual standards of quality in the country. At present, there is WHO GMP and Schedule M which is part of the Drugs and Cosmetics Act. D G Shah, secretary general, Indian Pharmaceutical Alliance, said the association has been urging the government to join PICS for some time. At present, over 50 regulatory bodies, including the US Food and Drug Administration (USFDA) and UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) are part of it. With PICS membership, comes a slew of benefits such as export facilitation, reduced duplication of inspections, and higher market access among others. India first needs to become an observer, prepare a roadmap and then it can apply for membership. The whole process takes around five to six years. In a recent meeting in August, the Center has decided to prepare a road map to be PICS compliant. – Business Standard