Indian excipient industry to approach DCGI to curb irrational usage of excipients in domestic market
The Indian excipient industry is planning to approach the Drugs Controller General of India (DCGI) to frame India specific guidelines to curb irrational usage of excipients in the domestic market.
There cannot be dual set of specifications and guidelines for the international and domestic market in a scenario where 70 per cent of excipients are imported, industry experts pinpoint.
According to industry sources, many foreign players have set up manufacturing facilities in the country which is also complemented with the ongoing effort of International Pharmaceutical Excipient Council (IPEC) to harmonise all pharmacopoeias including Indian Pharmacopoeia (IP) for effective regulatory compliance and hence drug quality.
Industry veterans have for long been advocating that 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, 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 IP.
There are 40 members in IPEC with India being the youngest member. Experts say that there is an urgent need to create synergies between manufacturers and consumers/users in the supply chain to understand stakeholders requirements in the evolving regulatory scenario.
It has been given to understand that Chinese Pharmacopoeia has included functional related characteristics (FRC) in monograph. This would 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.
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.
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.
IPEC India is planning 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 to develop products on the basis of quality by design (QbD) principle for robustness of the product performance inspite of variability between materials used in the formulation.
Currently excipients are clubbed with APIs under Drugs and Cosmetics (D& C) Act which requires a drug licence. Need is to bring industry and regulators on equal level to understand the global regulatory developments.
“Performance of the formulation depends on the excipient. It is equally important that excipient need to be safe. Product has to be bio-equivalent to the innovator product. Consistently keeping it bio-equivalent requires consistent quality of excipient,” experts conclude.