Mumbai:  All the excipients are going to be critical in the days to come with concerns around diethylene glycol (DEG) and ethylene glycol (EG) contamination in medicinal products. Excipients are equally important along with bulk drugs in the manufacture of finished drug products. It not only acts as a vehicle in the drug manufacturing process but also interacts with active pharmaceutical ingredient (API) to deliver a quality pharmaceutical product, said Udaya Bhaskar, director general (DG), Pharmaceuticals Export Promotion Council of India (Pharmexcil)

He was speaking on the sidelines of Mumbai chapter of Capacity Building Programme on “Pharmaceutical Quality Compliance and Foreign Trade –Industry Practices and Regulatory Expectations” organised by the Pharmexcil in Mumbai recently.

Echoing similar views, Ajit Singh, chairman, ACG Worldwide and SciTech Centre, said that in order to improve the overall good manufacturing practice (GMP), Schedule M should also consider incorporating audits and certification of pharma ancillary industries. These industries should not only include excipients but should also extend to all other materials which directly get in contact with the active formulation, like pharma machinery, packaging films and bottles among others.

Singh also stressed that besides excipients, the Government of India should also incentivise for pharma ancillary industries in a similar way it has introduced production linked incentive (PLI) scheme for bulk drugs in the country. The volume of excipients used in a formulation is several times more as compared to API.

“The government wants the bulk drug industry to grow multi-fold, and so there is a need for these ancillary industries like films, foils and bottles also to grow at a similar pace to achieve the desired growth in bulk drugs manufacturing,” he said.

Pharmexcil has launched Capacity Building Programme pan-India to create awareness on quality culture and enhance understanding of stakeholders in the domains of regulatory, GMP, quality and Safety norms.

“Complex non-transparent supply chains can lead to economically motivated or accidental adulteration,” cautioned Matruprasad, senior director, United States Pharmacopoeia (USP) while giving a presentation on “Importance of Excipient Quality and Development for use in Medicines: USP DEG tool kit and DEG/EG Identification (ID) test in Excipient Monographs. The presentation was jointly given by Matruprasad, senior director, USP and Dr. Devendra Chavan, senior scientist-II, Documentary Standards, USP.

Conceived in 1820, the USP is an independent, scientific, non-profit organization dedicated to improving public health. USP publishes a uniform set of guidelines and standards for medicinal substances and preparations.

Matruprasad further informed that Excipients can make up to about 90% of the total mass or volume of medicinal products. Some of the functional categories include lubricant, pH modifier and diluent among others. They often help ensure the API is delivered to the site of action.

To help the global community put an end to preventable deaths due to DEG contamination, USP is making a virtual tour kit for measuring and controlling levels of DEG available as a free resource to all interested stakeholders that will include relevant chapters monograph and other resources.

“In May 2023 FDA guidance for industry testing of glycerine, propylene glycol, maltitol solution, hydrogenated starch hydrolysate, sorbitol solution and other high-risk drug components for DEG and EG compliance to the identity standards in USP-NF monographs is required. According to the FDA guidance, the monograph has an ID test limiting EG and DEG as potential adulterants and contaminants. It is required to perform such identification tests on each shipment of each of the components to ensure that the component contains a permissible limit of NMT 0.1 % of EG and DEG before use in drug product manufacturing,” informed Dr. Devendra Chavan from USP.
USB collaborative efforts in 2007 to 2012 on updating the seven USD and NF monographs with the DEG ID test contributed to the May 2023 FDA guidance for the industry.

A presentation on Supplier Verification and Risk Management was presented by Vishakha Metkar, senior manager for regulatory affairs, South Asia, at Colorcon Asia Pvt Ltd. International Pharmaceutical Excipient Council (IPEC)-India.

The event also hosted a Stakeholders Consultative Session on Foreign Trade (Customs, DGFT and Special Rupee Vostro Mechanism). Mihir Ajit Shah, honorary advisor, Pharmexcil moderated the session. The Session was chaired by Tushar Korday, COA Member, Pharmexcil.

Panelists included Satya Raja Shekhar, deputy director general of foreign trade (DGFT), Indian Trade Service, M V Muthuraman, deputy general manager, Trade and Forex, Bank of Baroda, Lakshmi Prasanna, director, Regulatory Affairs, Pharmexcil and Akshay Patil, deputy commissioner, Customs.

A presentation was given by Dr. Rajeev Desai, senior technical advisor – quality and regulatory at IPA on Quality Management System (QMS) – Regulatory Compliance. Jayant Kumar, deputy drug controller (DDC) (India), Central Drugs Standard Control Organisation (CDSCO) gave a low down on Regulatory Expectations for Quality Compliance – Proposed Revisions of Schedule-M.

Rollins John, regional director-Mumbai, Pharmexcil conducted the proceedings of the event.

During the panel discussion, exporters and manufacturers were urged to submit data for review of Remission of Duties and Taxes on Exported products (RoDTEP) rates.

The RoDTEP scheme provides a mechanism for reimbursement of taxes, duties and levies, which are currently not being refunded under any other mechanism, at the Central, state and local level, but which are incurred by the export entities in the process of manufacture and distribution of exported products.