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The Indian pharmaceutical industry has long been supplying over 50 per cent of global demand for various vaccines, 40 per cent of generic demand in the US and 25 per cent of all medicines in the UK. There can be no two opinions about the fact that India is the largest provider of generic drugs globally. From a mere Rs. 10 crore in 1948 to more than Rs. 2 lakh crores at present, the Indian pharmaceutical industry has undisputedly grown by leaps and bounds. Indeed, it has come a long way to adorn the epithet of 'the pharmacy of the world', exporting affordable quality medicines to around 200 countries in the world, including the developed countries like the US and Europe. Of course, it is a great feat for a sector which was dominated by the multinational drug companies until 1970's. Unfortunately, the country is not a member of PIC/S (Pharmaceutical Inspection Cooperation Scheme) so far, which would have helped India maintain global standards and enhance global confidence in drugs coming from India. Even though PIC/S is not a trade agreement, membership in PIC/S will facilitate the export of pharmaceuticals. Some non-PIC/S authorities accept GMP certificates from PIC/S participating authorities. This means that non-PIC/S authorities and organisations have a greater confidence in medicines manufactured in countries where the regulatory authority is a PIC/S participating authority. Consequently, the pharmaceutical industry located in these countries indirectly benefits from PIC/S membership. A PIC/S membership reduces duplication of inspections, facilitates the industry in export, and provides huge market access among other benefits. Though the Indian government has been taking several initiatives to become a member of PIC/S, it did not bear fruit so far, probably because of the quality issues.
Under this background, the Union Health Ministry’s efforts to implement the Revised Schedule M for the Indian pharmaceutical industry will bring the pharmaceutical quality standards in the country on par with the international standards. Definitely, the Revised Schedule M will elevate India's stand as a globally recognized, regulatory-compliant nation, strengthening its participation in the PICS, showcasing its commitment to stringent quality and safety standards on an international platform. Of course, it is a right and timely move by the Health Ministry towards achieving global quality standards in the pharmaceutical industry. PIC/S is a non-binding, informal co-operative arrangement between regulatory authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any authority having a comparable GMP inspection system and its membership will help exporters significantly save cost and time. This elite group presently has 56 participating authorities across Europe, Africa, America, Asia and Australasia. Drug regulatory bodies from across the globe including the US, the UK, China, Canada, Japan, France, Germany, Australia, New Zealand, Italy, Mexico, South Africa, Spain, etc are all part of this group. PIC/S aims at harmonising inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to the drug inspectors. It also aims at facilitating co-operation and networking between competent authorities, regional and international organisations, thus increasing mutual confidence. No doubt, the Revised Schedule M has the potential to take India closer to get entry into the elite PIC/S group. Now that the Drugs Controller General of India is pulling up all stops to implement the Revised Schedule M in letter and spirit, the Union Commerce & Industry Ministry should leave no stone unturned to make this PIC/S membership dream a reality.
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