Indian Excipient Industry Needs To Adopt Global Harmonised Standards For Patient Safety

Indian Excipient Industry Needs To Adopt Global Harmonised Standards For Patient Safety

Mumbai, 27 July 2019:


There is a need for adoption of global harmonised standards by Indian excipients industry for patient safety even as the US, Europe and China have taken the lead. International Pharmaceutical Excipients Council (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). Besides this, around 70 per cent of excipients are imported in India barring a few.


These were some of the key deliberations by industry experts during an event hosted recently under the aegis of IPEC India themed “Understanding Regulatory Perspectives of Excipients” in Mumbai.


There are 40 members in IPEC with India being the youngest member. The meet was aimed at creating synergies between manufacturers and consumers/users in the supply chain to understand the stakeholders requirements in the evolving regulatory scenario.


“Meanwhile, Chinese Pharmacopoeia has included functional related characteristics (FRC) in monograph which will create imbalance under the current regulatory regime. But this would definitely help excipients to perform critical functional attributes for drug safety like particle size, mean particle size, bulk density, viscosity etc besides assay and chemical test,” explained Subodh Priolkar, vice chairman, IPEC India and CEO, Wincoat Colours and Coatings Pvt Ltd, Thane.


“Now, here the challenge lies in this context as regulated markets cannot modify GMP Requirements for Certificates of Analysis (CoA) according to Chinese regulations basis if there is a special material manufactured in China as per the local regulations. Just as if any regulated market comes out with a regulation on elemental impurities to comply with, it would be really difficult to comply when we are talking about global regulatory harmonisation,” Priolkar added.


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. 


Besides this only a few excipient players have upgraded their systems to meet the requirements of regulated markets as the excipient industry is highly unorganised. Therefore IPEC India is all set to upgrade quality standards in India, experts said adding that there is an urgent need for enhancement of GMP standards in Indian excipient industry to meet global regulatory market needs.


A case in point is the rate release polymer like hydroxypropyl methyl cellulose (HPMC) which needs test requirements for high viscosity besides chemical test, assay test and identification test.


Functional related characteristics (FRC) as mandated by China is aimed at making physical characteristics attributes to perform product performance and hence patient safety. This however is not included in the monograph of USP and BP and is hence not mandatory.


Industry should follow IPEC federation guidelines because when you develop products you apply quality by design (QbD) principle to ensure robustness of the product performance inspite 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. But inspite of all the variation, the product performance should not get affected. Therefore there need to be a plan in place to ensure that your product performance is stable.


According to Kaushik Desai, secretary general, IPEC India, “Currently excipients are clubbed with APIs under Drugs and Cosmetics (D& C) Act which requires a drug license. Therefore, excipients are no different. In the current scenario, the challenge is of compliance. There is a need to educate industry about global standards and the need to meet them. We have a long way to go as far as harmonisation is concerned. There are guidelines available which are taken up by IPEC federation for global use though they are not mandatory guidelines. Therefore, there is a need for India specific guidelines to fill the gap.”


Echoing similar views, Ex Maharashtra Food and Drug Administration (FDA) Joint Commissioner Nilesh Gandhi said, “IPEC should take efforts to create a platform to bring industry and regulators on equal level to understand the global regulatory development. This is very much relevant as industry talks about self-regulation and regulators talk about compliance and monitoring.”


Talking about the importance of excipients, Ex Maharashtra FDA Joint Commissioner O S Sadhwani said, “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. This is very much relevant as drug development has evolved to an extent that we make sure that there are no related unintentional impurities in the drug. The same applies for excipients which if not safe can lead to same drug formulation rendered ineffective or contaminated.”


“Therefore it is equally important that excipient need to be safe. One should know the quality of the excipient, then only you can design the product accordingly. Product has to be bio-equivalent to the innovator product. Consistently keeping it bio-equivalent, you need consistent quality of excipient. It needs to be designed to get the consistent quality by following good GMP standards,” he added.


On the occasion Rajesh Parab, managing director – South Asia, Colorcon Asia Pvt Ltd and member, Managing Committee -IPEC India spoke on emerging role of excipients in pharmaceuticals.


Vishakha Metkar, manager, Regulatory Affairs, Colorcon Asia Pvt Ltd and managing committee member and chairperson of Regulatory Affairs Committee, IPEC India spoke on excipient qualification and implementation of appropriate standards.


Mohan Kumar, head, External Manufacturing MSAT and AVD, Dr. Reddy’s Laboratories Ltd spoke on qualification of alternate vendor for excipients.


Dr. Ravleen Khurana, managing director, Nitika Pharmaceutical Specialties Pvt Ltd, Nagpur spoke on an integral role of QbD excipients in robust formulation. 


Prakash Gadhave, site manager, Colorcon Asia Pvt Ltd and member, Regulatory Affairs Committee, IPEC India spoke on Good Distribution Practices – A Challenge.

SOURCE : Pharmabiz