Dr. APPAJI’S PHARMA NOTES

Dr. Appaji PV

India’s Drug standards setting body ( Indian Pharmacopoeia Commission ) joins Pharmacopoeal Discussion Group ( PDG ) as member - great recognition and a boost to Indian pharma exports !

– The Pharmacopeial Discussion Group (PDG) was formed in 1989 . The members are :

the European Pharmacopoeia ,
the Japanese Pharmacopoeia and
the U.S. Pharmacopeia .

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– PDG generally meets regularly and works to advance drug standards harmonization work.

Hormonization will reduce manufacturers’ burden of having to perform analytical procedures in different ways, using different acceptance criteria, in order to satisfy pharmacopoeial requirements that vary across countries / countries.

– PDG selected IPC last year as a pilot member and after one year invited IPC to be its permanent member.

– It will establish IP as progressive pharmacopoeia which designs drug quality standards at par with global standards.

Application of these standards will lead to production of world class pharmaceutical products for domestic and export market.

Benifits of PDG Membership:

International Recognition.
Improved Regulatory Compliance.
Access to Global Markets:
Global Health Impact.

– this is a great recognition of the capabilities of IPC and would contribute to export growth .

Another production-linked incentive scheme ( PLI ) for making India self-dependent in medicines – an excellent progressive step by Govt.

– Govt has earlier announced PLI scheme with fund support of Rs 6940 Cr to encourage local production of some 53 identified bulk drugs / DIs / KSMs and make India free from import dependence for these very critically required drugs in the country. The proposal is highly appreciated and implementation of the scheme has just started.

– Today Govt has announced another PLI scheme for making India self-dependent in other sectors.

– Very happy to note that Govt has included the Pharma sector also again with fund support of Rs 15000 Cr for this sector alone.

– This is in addition to the first PLI scheme.

– The drugs included in this scheme are placed under three categories.

– Most of the drugs in the first category are high-technology drugs. The second category consists of APIs / DIs / KSMs not covered in PLI scheme -1. The third category includes important formulations of different therapies and includes phytopharmaceuticals which give a boost to botanical medicines.

– Happy to note that Dr. Eswar Reddy, Joint DCGI, CDSCO has again contributed his technical expertise in finalization of policy.

– DOP will soon announce details.

Dt 2.12.2020.

Dr Yusuf Hamied, Chairman of Cipla and a great contributor to Global control of HIV – Cambridge University honours him by naming its Chemistry Department – great honour to Indian scientist and Indian pharmaceutical industry.

– Dr Hamied’s contributions to Indian / global population with generic drug versions of several critical care / HIV drugs is well known.

– Perhaps he may the first in India who pioneered in developing non-infringing processes through his knowledge in process chemistry and introduced several new drugs in India while they were still protected under ‘ product patent ‘ system in other countries.

– He always tried to provide quality drugs at very affordable prices to the Indian population.

– Hamied’s honours include an honorary fellowship of Christ’s College in 2004; the Padma Bhushan in 2005; an honorary fellowship of the Royal Society of Chemistry in 2012 etc.

– As a mid-level govt officer in Delhi, I was fortunate to understand his contributions from Govt side but there was a lot of misunderstanding due to wrong communications from their Delhi person. I suffered a lot with allegations against me.

– Dr Hamied’s contributions to Indian / global population in the healthcare sector are extraordinary. 🙏🙏🙏.

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