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The Indian pharma excipient manufacturers are now aggressively working to improve their quality standards of manufacture to decrease the import dependency. Currently 70 per cent of the excipients are imported and China is a large source of theses imports. Only a meagre 30 per cent is manufactured in India which is largely by small companies.
The sector is also bogged down by several issues including access to input raw material, and paucity of skilled workers to carry out the production processes. This is the main reason for many companies to depend on imports across the globe as domestic players are unable to match the competitive pricing and the demand. Hence most active pharmaceutical ingredient (API) and formulation companies prefer to use imported excipients, said Vishaka Metkar, chairperson, sub-committee, regulatory affairs, International Pharmaceutical Excipients Council of India (IPEC) and regulatory affairs manager, Colorcon Asia.
Many a time, the stringent requirements by pharmaceutical companies make it difficult for excipient suppliers to cater to the supply orders. Largely, the Indian excipient players are small, fragmented and lack the global exposure which affects them to upgrade their manufacturing standards. However, if excipient companies brace up to improve, then their profit margins from the pharmaceutical sector alone would be higher than their investments in production, Metkar told Pharmabiz.
There are hardly a few large-scale manufacturers and 30% of domestic production is by small players. Upgrading to current standards of manufacture, monographs and other requirements is necessary if the sector needs to be represented in the global arena, she said.
Even in the area of regulations, India needs a dedicated guideline for excipients in India. Currently, it is considered as an API and same guidelines apply. Few excipient players have upgraded their systems to meet the requirements of regulated markets but that is not enough. Though the US and Europe are a part of the global harmonization process, China has been following its local stringent guidelines which has made Indian excipient industry to look at regulated markets for competitiveness and product quality.
This leaves India to import 70% of excipients and the remaining 30% is from its source of domestic production. As of today the Indian excipient industry heavily relies on European and US sources for its drugs for the regulated markets and China for its domestic market consumption.
Besides compliance to GMP standards and IPEC guidelines, there is need for investments by Indian companies to manufacture major excipients like lactose, hydroxypropyl methyl cellulose (HPMC), micro-crystalline cellulose (MCC), polyvinylpyrrolidone (PVP), among others.
Recently, IPEC, a federating body representing America, Europe, Japan, China and India released revised version of the Excipient Information Package (EIP) user guide as this has become the industry norm globally. Many excipient users now ask their suppliers for their EIP during the qualification process rather than using their own procedures.
Indian excipient industry will benefit from this document as it will bring them in line with the global requirements. They can respond in a timely and efficient manner while ensuring that consistent and accurate information is provided than filling various forms from various customers. This process assists both users and suppliers, said Metkar who has been a team member representing IPEC India in framing the guideline.
IPEC India with support from its global body brings several guidelines on Data Integrity, Excipient Composition Guide, GMP, Quality Agreement and varied allied subjects exclusively for the benefit of the manufacturers and suppliers in the country.
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