Page 146 - CW E-Magazine (5-12-2023)

Pharmaceuticals Pharmaceuticals

MOVING UP THE VALUE CHAIN INDIGENISATION EFFORTS

DCGI emphasises need to focus on pharma innovation Generic drugs to treat four rare diseases launched

The Drug Controller General of Linked Incentive (PLI) schemes, and Providing relief to patients with rare will now be made available for “This venture is purely a non-com-
India (DCGI), Mr. Rajeev Raghuvanshi, medical device parks working for the diseases across India, the Union Health children. mercial venture guided only with the
has emphasised that the Indian pharma- medical devices sector as well. Ministry has made available generic motive to serve those in acute need.
ceutical industry needs to bring in a drugs to support the care and treatment A rare disease is a health condition For years, the Health Ministry through
shift in their mindset and also bring in The event also saw the launch of the of four ailments: Tyrosinemia-Type 1, of particularly low prevalence that various schemes has been trying to
more money into research and develop- ‘Reimagining Pharma and Healthcare Gauchers Disease, Wilson’s Disease, affects a small number of people. It col- fi nancially help as many patients as
ment. The DCGI underlined the need to for India@100’ report, a collaboration and the Dravet-Lennox Gastaut Syn- lectively affl icts 6-8% of the population possible, but this is a more sustainable
shift the focus from volume to value in between OPPI and EY Parthenon, the drome. This means that the cost of these in any country at any given time. measure for not just patients in India
order to maintain India’s position as the summit’s knowledge partner. drugs will be slashed by anywhere be- Nearly 80% of these diseases are but also worldwide,” he said.
‘pharmacy of the world.’ tween 60 and 100 times of their current genetic in nature.
While novel drug development promi- market value. Dr. Paul added that the Ministry was
He was speaking at the Annual we need to drive innovation and start a ses high returns, it also requires a high Priority diseases also engaging with companies who are
Summit of Organisation of Pharma- mass movement there as well,” he said. investment of time and resources. In the The Ministry is also in the process “To bring in these drugs a special initi- selling patented rare disease drugs. “We
ceutical Producers of India (OPPI), in OPPI-EY survey, the need for substantial of making available drugs for more ative was taken, and discussions were are actively looking at how best to work
New Delhi. He emphasised that India needs to investments over an extended gestation rare diseases, including Phenylketonuria held with academia, pharma industries, for patients who urgently need these
enhance its ‘value game’ as we have period, coupled with high risk of failure, and Hyperammonemia, over the next organisations, the Drug Controller, and medicines,” he explained.
“We need to bring a shift in the already established the leadership emerged as the key barriers impeding the few months. “The approvals for these the Department of Pharmaceuticals.
mindset, since most of us are still position of the generic model. industry’s innovation journey. drugs are awaited,” said Mr. V.K. Paul, Thirteen rare diseases were prioritised. Several companies – including Bio-
thinking with respect to the generics Member, NITI Aayog. He added that We particularly worked on sickle cell phore India, Laurus Labs, Azico Bio-
model, because it has become so Mr. Raghuvanshi highlighted that “India needs to establish a compre- this initiative would also result in disease, and on the syrup for children phore, MSN Pharmaceuticals, and
successful. The problem lies in the fact as a philosophy, the Indian Government hensive regulatory data protection patients’ costs dropping from-crores under fi ve who can’t be administered Akums Drugs and Pharmaceutical –
that people in the pharma sector mostly has recognised that there is a need to framework and bolster the IP environ- annually to mere lakhs. Additionally, tablets,” said Health Minister Mr. Man- have come forward to take part in the
wait for a reference, and then start shift from volume to value and policies ment and enforcement. This will have a sickle cell disease drug formulation sukh Mandaviya. venture.
working on something. There are very are framed around pushing this shift. a profound positive impact on India’s
few people who take the initiative and For instance, he said the recent R&D innovation ecosystem and enhance
start innovating on their own. So, just policy by the Department of Pharma- patients’ access to cutting-edge treat- SUBLICENSING DEAL
like how the development of generics ceuticals was created to promote inno- ments,” said Mr. Anil Matai, Director Orchid Pharma’s Q2 net surges; to manufacture
has become a mass movement in India, vation and there are many Production General, OPPI.
cefi dorocol
EXIT PLANS

Orchid Pharma Ltd., a vertically inte-
“The purpose of this agreement is to volves two aspects. For the API,
AstraZeneca Pharma India plans to sell Bengaluru grated pharmaceutical company, said give Orchid rights to manufacture this we will utilise the existing facility,
plant it has been selected through a global patented product for 135 countries of incurring a relatively modest cost.
low- and middle-income group,” he However, for the finished dose for-
tender for the manufacture of Cefi doro-
AstraZeneca Pharma India plans to manufactured or packaged at the site, col. Cefi dorocol is employed in the added. mulations, a new plant will be esta-
sell its production facility in Bengaluru subject to receipt of necessary statu- treatment of complex urinary tract blished, requiring an investment in
as part of a strategic review of global tory approvals, the drug fi rm said. infections (including pyelonephritis) in Shionogi will directly transfer the the range of Rs. 80 to Rs. 100-crore,”
manufacturing and supply network by AstraZeneca Pharma India’s Bengaluru patients with restricted or no alternative technology for this product to Orchid. added Mr. Dhanuka.
its parent, according to a regulatory facility is one of the nine global sites treatment alternatives. Shionogi aims to grant access to the
fi ling. that support the design and conduct those in low-income countries, address- The company also released its Q2
of clinical trials, monitoring of safety The sublicensing agreement with ing the escalating issue of antimicrobial results recently for FY24. The compa-
“As a part of AstraZeneca’s ongo- The company will position the and effi cacy and other regulatory man- Shionogi of Japan, facilitated through resistance, said Mr. Dhanuka. The ny’s Q2 revenue reached Rs. 199-crore,
ing strategic review of its global manu manufacturing site for sale in a fully agement required during a product’s GARDP (Global Antibiotic R&D Part- product is likely to be launched in the from Rs. 165.2-crore in the same
facturing and supply network, the com- operational manner and begin a lifecycle. AstraZeneca Pharma India, nership), will allow Orchid to produce second half of 2026. quarter last year. The quarterly net
pany intends to exit the manufacturing search for a buyer who can also act a subsidiary of AstraZeneca Plc, UK, this crucial product, said Mr. Manish profi t in September 2023 surged to
site in Bangalore, in due course,” it as a contract manufacturing organisa- was established in 1979 and is head- Dhanuka, MD of the company, during “Regarding the new agreement Rs. 20.24-crore, up from Rs. 3.32-crore
said. tion (CMO) for its products currently quartered in Bengaluru. the Q2 FY24 earnings conference call. for Cefidorocol, the investment in- in September 2022.

146 Chemical Weekly December 5, 2023 Chemical Weekly December 5, 2023 147

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