Page 147 - CW E-Magazine (24-10-2023)

Pharmaceuticals Pharmaceuticals

PARTNERSHIP HARMONISING STANDARDS

Granules, NIPER to set up Centre of Excellence Indian Pharmacopoeia Commission inducted into

Hyderabad-based Granules India and global league as permanent member
the National Institute of Pharmaceutical
Education and Research (NIPER), India has joined a global effort to different ways, using different accep- benefi t from the exchange of infor-
Mohali, Chandigarh, have entered into harmonise various pharmacopoeias, tance criteria, in order to satisfy pharma- mation and best practices with other
a Memorandum of Understanding which are lists of medicinal drugs with copoeial requirements that vary across members, helping India in aligning its
(MoU) to establish the Chigurupati their effects and directions for use, regions.” regulatory processes and practices with
Centre of Excellence in Innovative and the government said in a statement. global standards. It will contribute to
Sustainable Pharmaceutical Develop- A standardised pharmacopoeia will The Indian commission’s member- the global effort to ensure the safety and
ment (CCE-ISPD). make it easier for drugmakers to adhere ship to the global group will signifi cantly effi cacy of marketed pharmaceutical
to procedural norms for multiple markets. increase the visibility of the Indian products having a direct impact on public
Work in crucial areas such as ex- Pharmacopoeia on an international plat- health worldwide, as it would help to
ploring plant-based excipients, advance- The Indian Pharmacopoeia Com- form and recognition of standards set prevent the circulation of substandard or
ments in polymer-free pharmaceuti- mission has offi cially joined as a mem- by it by other countries. counterfeit drugs.
cal formulations, innovative methods in ber in the Pharmacopoeial Discussion
producing directly compressible crystals, Group (PDG), which was established The move will establish IP as pro- The World Health Organization is
promotion of solvent-free pharmaceuti- but to make a difference,” Mr. Krishna said, “The CCE-ISPD will be a nur- in 1989 to harmonise pharmacopeial gressive pharmacopoeia that designs an observer of the group. The PDG
cal processes and the development of Prasad Chigurupati, Chairman and turing ground for innovative ideas and standards in the world, the statement drug quality standards at par with announced the Indian Pharmacopoeia
resource-effi cient and energy-effi cient Managing Director of Granules India sustainable solutions, shaping the future said. global standards, according to the health Commission as one of its members on
pharmaceutical products will be the said in a release. “The CCE-ISPD is a of pharmaceuticals.” ministry. Application of these standards October 5 during a stakeholder meeting
focus of the proposed centre. testament to our dedication to sustain- Typically, pharmacopoeia in the will lead to production of world-class in Hyderabad, the government statement
able pharmaceutical development, and Granules India has committed sup- modern parlance is defi ned as a book pharmaceutical products for domestic said. The group’s pilot for global expan-
“At Granules India, we are commit- we are enthusiastic about the transfor- port for the establishment and conti- that contains directions for identifi - and export markets, it said. sion started in September last year.
ted to pushing the boundaries of pharma mative impact it will have on industry nuous operation of the research centre. cation of compound medicines and
ceutical innovation, and through this and society,’’ he added. The partnership includes the establish- published by an authority (Government) It will also help the local com- “IPC was only Pharmacopoeia
partnership with NIPER, we aim not ment of laboratories and research faci- or a medical or pharmaceutical society. mission to collaborate and harmonise body in the world to be selected for
just to make life saving medicines, Prof. Dulal Panda, Director, NIPER lities within the NIPER campus. pharmacopoeial standards with other pilot phase initiated in September 2022.
POOLING RESOURCES “The PDG will now bring together major regulatory or standard setting After reviewing each application, the
the European Pharmacopoeia (Ph. Eur.), authorities, leading potentially to improve PDG agreed by consensus, to start
C-CAMP to build Centre of Excellence in antimicrobial the Japanese Pharmacopoeia (JP), the the acceptance of Indian medicinal the pilot phase with the IPC, the only
United States Pharmacopeia (USP) products in global markets, as they applicant that met all the requirements
resistance innovation with SBI Foundation and Indian Pharmacopoeia (IP) to adhere to globally recognised quality in the entry criteria for the pilot,” the
harmonise global pharmacopoeial standards. In the long run, it will reduce statement said. “This represented IPC’s
Antimicrobial resistance (AMR) is globally with a projected fatality rate C-CAMP Director-CEO Dr. Tasli- standards,” it said. “The objective is to trade barriers. continued commitment and capability to
the focus of a new partnership between of 10-million per year by 2050. marif Saiyed said, “As the latest ICMR reduce manufacturers’ burden of hav- develop world-class quality standards for
Bengaluru-based Centre for Cellular and study on AMR showed, last-resort anti- ing to perform analytical procedures in The Indian commission will also drugs and pharmaceuticals.”
Molecular Platforms (C-CAMP) and Announcing the initiative, Prof. biotics like carbapenems are beginning
SBI Foundation (SBIF). The project will Ajay Sood, Principal Scientifi c Adviser to fail in hospital-acquired infections
establish a Centre of Excellence (CoE) to the Govt. of India, said “AMR poses in ICUs with signs of locally resistant Global Bio-India 2023 to be held in December in
in AMR innovation by providing a a grave challenge to public health sys- strains emerging. This implies a dire
structured platform for support systems tems across the world and is a WHO need for indigenous solutions tailored New Delhi
and frameworks to advance the deve- priority. Paradoxically, AMR is one for Indian conditions which this CoE Department of Biotechnology (DBT) sations, regulatory bodies, Central and of more than 50 countries, more than
lopment, translation and scale-up of of the least funded domains in bio- will help identify and support.” and Biotechnology Industry Research State Ministries, SMEs, large industries, 500 exhibitors, and more than 5,000
indigenous deep science entrepreneur- technology due to its skewed market Assistance Council (BIRAC) are organi- bioclusters, research institutes, inves- delegates.
ships in AMR domain. economics. Funding and handholding The CoE plans to kick off its ope-
support for this deep science sector by rations by identifying and nurturing up sing Global Bio-India 2023, at Pragati tors, and the startup ecosystem. With the
AMR has been identifi ed by WHO the C-CAMP-SBIF CoE will be tre- to 12 innovations in the next two years. Maidan, New Delhi, on 4-6 December theme ‘Transforming lives biosciences The Indian biotechnology industry
as one of the top ten global health mendous boost for AMR innovation A nation-wide India AMR Grand Chal- 2023. The mega international congre- to bioeconomy’, Global Bio-India was valued at $93.1-bn in 2022, with
threats claiming 700,000 lives per year development.” lenges call is to be announced soon. gation will feature international organi- 2023 is expected to see the participation expectations of reaching $300-bn by 2030.

146 Chemical Weekly October 24, 2023 Chemical Weekly October 24, 2023 147

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