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The International Pharmaceutical Excipients Council (IPEC), India is all set to roll out a series of webinars on raising good manufacturing practices (GMP) standards for excipient quality to educate manufacturers for preparedness in terms of regulatory and compliance issues in the wake of COVID-19 pandemic. The webinars are likely to start from next week.
Performance of the formulation depends on the excipient. It has an important role to play in terms of how the product behaves, how it releases the drug and at what rate it releases the drug.
As of today, only a few excipient players have upgraded their systems to meet the requirements of regulated markets as the excipient industry is highly unorganised. Though the US and Europe are a part of the global harmonization process, China has been following their local stringent guidelines which has made Indian excipient industry to look out for regulated markets for competitiveness and quality of the products.
There are 40 members in IPEC with India being the youngest member and its aim is to create synergies between manufacturers and consumers or users in the supply chain to understand the stakeholders’ requirements in the evolving regulatory scenario. As of today, 70% of excipients are imported and 30% is domestic production which is represented by small players. The excipient industry is looking for incentivisation to pave way for some certain scale of operation with big investments at a time when Prime Minister Narendra Modi has made an announcement to promote small and medium enterprises in his national address yesterday.
“Besides the compliance to GMP standards and IPEC guidelines, big investment has to come so that Indian excipient industry can manufacture major excipients like lactose, hydroxypropyl methyl cellulose (HPMC), micro-crystalline cellulose (MCC), polyvinylpyrrolidone (PVP) among others. As of today the Indian excipient industry heavily relies on European and US sources for regulated markets and Chinese sources for domestic market,” explained Subodh Priolkar, vice chairman, IPEC India and CEO, Wincoat Colours and Coatings Pvt Ltd, India.
Out of total API import, India’s dependability for API and KSM is 68% on China, 3% on Italy, 2% on Hong Kong, 3% on Singapore, 4% on US and 20% on other countries. Government of India has come forward with a very attractive scheme of incentive that will be given to the manufacturers of fermentation based products and 10% incentive will be given to those manufacturers who produce synthesized chemical based API or intermediates.
Experts have pinpointed that there is a need for adoption of global harmonised standards by Indian excipients industry for patient safety. IPEC India has therefore set the agenda to harmonise regional guidelines to gradually achieve and adopt global harmonised standards.
Industry advocates that the situation in India warrants action as there is no regulation in India apart from monograph on excipients mentioned in Indian Pharmacopoeia (IP).
Experts further pinpointed that there is an International Council of Harmonisation (ICH) in place for formulations with the US, Europe and Japan as key members and India having an observer status. There is hardly any progress in this regard as far as excipients are concerned. ICH has been existence for the last 13 years. A similar kind of regime is required to raise quality and GMP standards for excipients as well.
Industry should follow IPEC federation guidelines to apply quality by design (QbD) principle to ensure robustness of the product performance in spite of variability between all materials used in the formulation. APIs has certain limits and excipients also have certain limits. So, one batch may vary from the second batch. In spite of all the variations, it has to be ensured that the product performance should not get affected. Therefore there needs to be a plan in place to ensure that your product performance is stable.
There are guidelines available which are taken up by IPEC federation for global use though they are not mandatory guidelines. Therefore, experts advocate there is a need for India specific guidelines to fill the gap.
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