Budget 2018: Pharma Companies Want A Push On Research, Innovation

The government needs to seriously re-think the ways to promote research and innovation in the country, especially within the Indian pharmaceutical industry. This seems to be coming across as a clear message from the various stakeholders in the Indian pharmaceutical industry.

Perhaps, some of it has to do with the mood within the industry driven by the changing market dynamics in the two most important markets – the US and India, and the fact that most recent budgets have been largely disappointing for the sector.

Many companies, with some leading players, are already coping with challenges around price erosion in generics, erosion of base business resulting from new competition and buyer consolidation in their biggest global market, the US. They clearly see the writing on the wall: Moving up the value chain in terms of developing niche, hard to replicate products, is the only way out and are gearing up for that, with some already moving ahead in this journey.

This is one reason why most that Business Today spoke to were unanimous in picking research and innovation as the top item on the list of priorities for the sector. But then, given that research spending in the pharmaceutical industry is a risky proposition, especially in areas of drug discovery and innovation, fiscal incentives could provide the necessary fillip.

For instance, it is very likely that even after spending 10 years investing in research, the product may finally not get a regulatory approval. “If you want to promote innovation then incentivize investments into research and innovation. This could be done either by government offering a matching grant to a private enterprise or by extending a tax credit,” says D G Shah, secretary-general at the Indian Pharmaceutical Alliance, that has leading Indian pharma companies as its members.

He feels the tax credit could be spread over a period of two to three years also. This backed by some procedural simplifications, say around ease in filing of patents, could go a long way in encouraging research, he feels hoping the Union Budget would address this issue.

In fact, Kiran Mazumdar-Shaw, chairperson and managing director, Biocon, goes a step further and says, if India needs to move the needle with respect to its goals around Making in India and carving out a niche for itself globally, it needs to support research and innovation.

“India needs to spend at 2 to 3 percent of GDP on science and research as against the 0.69 percent at present,” she says.
According to a recent report by the department of science and technology, India’s gross expenditure on R&D as a percentage of GDP for the last couple of years has been at around 0.69 percent.

But then, if funds are an issue, her suggestion: perhaps the government could look at deploying collections made from the R&D cess. There are enough media reports on the over Rs 7,000 crore that have have been collected by way of R&D cess.

This is crucial, she feels and points to a recent report by the European Commission which says that if you increase R&D investment by 10 percent in public research institutions, it grows the GDP by 1 percent. This coupled with a focus on meritocracy could go a long way in the Indian context, she feels.

Kiran Mazumdar-Shaw and others in the pharma industry, while not in favour of the government move towards gradually doing away with the weighted deduction on R&D for the private sector, want its scope expanded to all areas connected with R&D.

This is despite the government’s roadmap that seems to favour a move towards a system where there is a reduced corporate tax rate with all the deductions eliminated, apparently to make it all simple.

“The budget should ensure that the weighted deduction on R&D is brought back (from 150 percent) to 200 percent and its scope expanded to cover various nuances of R&D such as in-house intangible asset development, expenditure on R&D facility, clinical trials by CROs (contract research organisations),” says Kedar Upadhye, Global Chief Financial Officer at Cipla, a global major pharma player with significant presence in the Indian market.

That apart, there is also an expectation that perhaps the budget would look at clearing some of the issues around GST payment, especially in cases where medicines cannot be sold, either on account of being damaged or for crossing their expiry date.

This article originally appeared in Business Today

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We wish you a very happy 72nd Indian Independence Day!

Seven decades after our historic tryst with destiny, on 15 August 2018, India will celebrate 72 years of independence, democracy and sovereignty. Presenting some interesting snippets from the archives on this occasion.

“India was officially proclaimed independent on 15th August 1947 with much celebrations in Delhi and other towns. Cipla celebrated the first Independence Day by a flag hoisting ceremony where all workers and staff of Cipla were present.”

– Dr. Khwaja Abdul Hamied,
Founder, Cipla.
‘A Life To Remember – An Autobiography’ (1972)

This is how India’s first Independence Day was celebrated by Cipla. The tricoloured Indian national flag was proudly unfurled and hoisted and the venue was Cipla’s very first manufacturing site and headquarters in Mumbai Central.

Seen here, Cipla Founder, Dr. K.A. Hamied, with his two young sons Dr. Y.K. Hamied and Mr. M.K. Hamied along with the factory staff and workers.

Cipla’s celebration of Indian independence did not end there. As a nationalist and freedom fighter, Dr. K.A. Hamied ensured that Cipla as an employer played its part in making the occasion unforgettable for Ciplaites by announcing a generous Independence Bonus!

The late Dr. A.R. Kidwai was a multi-faceted personality – public servant, scholar, statesman extraordinaire of post-independence India. Dr. Kidwai was a Cipla chemist from 1941 to 1945 and was witness to early scientific projects of Cipla as well as the involvement of then Ciplaites in the independence movement. Here’s a snippet of his reflections from the Oral History collection of the archives.

This advertisement placed by Cipla in the 1948 edition of the journal, Marg is a strong reminder of how Cipla was a trail-blazer in pharma R&D, quality and manufacturing in India, and saw itself as second to none. Spend a minute or two to read it with its context in mind – a time of euphoria, great promise, unrealised potential. A time when the state of India would finally attain equality in status with others on the world stage. Cipla’s strides were a microcosm of India’s in so many ways.

On that note, we wish you a very happy 72nd Indian Independence Day!

Cipla Receives Final Approval for Generic Reyataz® (Atazanavir Caps 100mg, 150mg, 200mg, 300mg)

Press Release

Cipla Limited (“Cipla”) today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Atazanavir Caps 100mg, 150mg, 200mg, 300mg from the United States Food
and Drug Administration (US FDA).

Cipla’s Atazanavir Caps 100mg, 150mg, 200mg, 300mg is AB-rated generic therapeutic equivalent version of Bristol-Myers Squibb Pharma Company’s, Reyataz®. It is a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients with minimum age of 6 years and older weighing at least 15 kg.

According to IQVIA (IMS Health), Reyataz® and its generic equivalents had US sales of approximately $324M for the 12-month period ending April 2018.

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Cipla partners with MSN Laboratories for marketing and distribution of generic Xeloda® (Capecitabine Tabs 150mg and 500mg)

Press Release

Cipla USA, Inc., (“Cipla”) a subsidiary of Cipla Limited, today announced that it has secured rights from MSN Laboratories Private Limited to market & distribute Capecitabine 150mg and 500mg tablets in the United States of America. The product is available immediately.

The Capecitabine 150mg and 500mg tablet is an AB-rated generic therapeutic equivalent version of Genentech’s Xeloda®. Capecitabine tablets are indicated as a single agent for adjuvant treatment in patients with Dukes C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred, and also indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.

As per IQVIA (IMS Health), Xeloda® and its generic equivalents had sales of approximately $178M for the 12-month period ending June 2018 in the United States.

About MSN Group
Founded in 2003 with a mission to make health care affordable, the MSN Group based out of Hyderabad is one of the fastest growing research-based pharmaceutical company in India. MSN has 10 API (including Oncology) and
five finished dosage facilities out of which three in Hyderabad, one both in USA & Myanmar. MSN Labs has an integrated R&D Center for both API and product formulation under one roof. The company’s core strategy will be to focus on high barrier of entry & first to market paragraph 4 products. MSN customer base exceeds 250 customers with a global presence in 65 countries throughout US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. With more than 350 National & International patents filed, MSN’s product basket offers 300 APIs & 200 Formulations covering 35 major therapies.

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Cipla Receives USFDA Approval for Generic Voltaren® Gel (Diclofenac Sodium Topical Gel, 1%)

Press Release

Cipla Limited (“Cipla”) announced that it has received final approval on August 3, 2018, for its Abbreviated New Drug Application (ANDA) for Diclofenac Sodium Topical Gel, 1% from the United States Food and Drug Administration (US FDA).

Cipla’s Diclofenac Sodium Topical Gel, 1% is AB-rated generic therapeutic equivalent to the reference listed drug (RLD), Voltaren® Gel, 1% of GlaxoSmithKline Consumer Health®. It is a non-steroidal anti-inflammatory drug
indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.

According to IQVIA (IMS Health), Voltaren® Gel and its generic equivalents had US sales of approximately $353M for the 12-month period ending June 2018. The product will be available for shipping in the US in the upcoming week.

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