The Indian health regulator now requires more information if any changes are made to the manufacturing processes of biological drugs in India once they have been approved for marketing, News18 has learnt.
To bolster the production of biological drugs in India, which are considered to be the next big thing in the Indian pharmaceutical market as per value as well as public health requirements, the Drug Controller General of India (DCGI) is harmonising standards of made-in-India biological drugs with globally recognised best practices, including WHO.
According to the latest notice issued by DCGI Rajeev Raghuvanshi dated February 28, the government has prepared a draft guidance for the industry in consultation with the stakeholders “to align with international guidelines, including those of the WHO and current international practices by various regulatory agencies.”
“The suggestions, comments, and objections from the stakeholders may be forwarded within 45 days from the date of issuance of this notice,” DCGI wrote, adding that these suggestions will be “considered for the finalisation of the draft guidance document”.
The draft document has been upgraded as per the recently tweaked Schedule M alongside ensuring compliance with global regulatory standards.
Addition of another category
It was 2007 when India last updated the guidance document using references from the Health Regulatory Agency of Canada and the WHO. However, WHO in 2018 and Canada in 2019 amended their documents as per the new requirements.
India has planned to make the move now.
Examples of biological products, according to the 119-page guidance document, include vaccine recombinant DNA products, biological drugs, cell and gene therapy products, and blood and blood products.
The maker of biological products needs to inform the regulator with possible data and documents in case of making any changes. In the case of biological products or vaccines, certain changes — whether it involves tweaking its formula, modifying premises, or upgrading equipment — could result in the quality, performance, efficacy and safety of the medicines.
Earlier, there were three key categories of changes — major quality changes, minor quality changes and moderate quality changes. Now, the draft has added one more category as a “record of changes”.
Under the new category, the regulatory agency has insisted on making a record of even the smallest changes, such as changes in the floor plan (which do not even impact the production process) or replacement or addition of filter housing in the manufacturing unit.
Even if it’s a “change in stopper cap colour for an injectable product” or a “room upgrade, such as installation of improved finishes on floors/walls” — the details need to be documented properly.
“Level IV (Quality only) changes are changes to a biological product that are not Level I, Level II or Level III and are not expected to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as these factors may relate to the safety and/or efficacy of the drug product,” said the draft.
“The changes included in this reporting category may be implemented by the marketing authority (MA) holders without prior review by CDSCO. The changes should be retained as part of the drug product’s record by MA holders and should comply with the requirements of good manufacturing practices.”
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