Last Updated on October 13, 2020 by The Health Master
The Department of Pharmaceuticals (DoP) is working on a short term production linked incentive (PLI) scheme to boost domestic manufacturing of excipients. Currently, India imports 95% of its requirements from regulated markets like the US, Europe and China.
The DoP has taken initiative to come out with PLI scheme for excipients following an appeal by industry representatives. The scheme will decrease Indian drug makers’ dependency on other countries.
Said Dr Dinesh Dua, chairman, Pharmexcil who is among those who called on DoP seeking extension of PLI scheme to promote domestic manufacturing of excipients, “Introducing PLI scheme to boost domestic manufacturing of APIs is not an end; the scheme needs to be extended to excipient manufacturing as well. India largely imports excipients from regulated markets which is quite expensive. We should incentivize excipient manufacturing and make sure that this industry comes up concurrently with formulation industry so that right quality excipients would be available at right price in the country.”
Dr Dua while speaking at a webinar “Pharma Intermediates & APIs: Chemistry of Growth Ingredients” said “We have been assured by the DoP that it would come up with short term PLI scheme to spur domestic manufacturing of excipients.”
We are hopeful of next round of incentivization would be towards excipients, he said.
Premchand Godha, chairman and managing director of Ipca Laboratories which imports starch from USA, basic material of producing excipients for its formulations marketed there, said “We lack interest in standardizing manufacturing of excipients at par with regulated markets. Besides incentive scheme, the technology upgradation is required to produce right excipients for the formulations.”
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Europe and North America account for about 75 per cent of the global excipients market. The excipient manufacturing in India is still at a nascent stage. Some of the leading names in pharmaceutical excipients in the country are ACG Worldwide, Colorcon, Indchem International, Micro Labs, Dow Chemicals, Lubrizol India, BASF India, SPI Pharma and Merck Groups.
A lot of starch based excipients of different commercial grades are produced from starch plants in the country after chemicals or physical processing. Commercial grade micro-crystalline cellulose is available from cellulose powder manufacturers, by which chemical and processing are converted to excipients. However, Indian excipient manufacturers depend on import components.
An excipient is a substance formulated alongside the active ingredient of a medication, included for the purpose of long-term stabilization, bulking up solid formulations that contain potent active ingredients (thus often referred to as “bulking agents”, “fillers” or “diluents”), or to confer a therapeutic enhancement on the active ingredient in the final dosage form, such as facilitating drug absorption, reducing viscosity, or enhancing solubility.
Excipients can also be useful in the manufacturing process, to aid in the handling of the active substance concerned such as by facilitating powder flowability or non-stick properties, in addition to aiding in vitro stability such as prevention of denaturation or aggregation over the expected shelf life. The selection of appropriate excipients also depends upon the route of administration and the dosage form, as well as the active ingredient and other factors.
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