Page 9 - GlaxoSmithKline Pharmaceuticals AR 2012

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provide access of the Company’s products in small villages and which also provides continuing
medical education to doctors in these remote geographies has met with continued success.
The collaboration initiative between your Company and the Consumer Healthcare Company
owned by the parent organization with a view to improving access of our products to patients
has commenced well. As a part of this initiative the mass markets business of your Company
launched products in patient nutrition by launching the brands ActiBase and ActiGrow.
Your Company is already a leader in providing a solution for gout and expanded its offerings
by launching Febuxostat, again, for the treatment of gout.
International evidence clearly suggests that disease prevention remains a more cost effective
health economic intervention than therapy. Consistent with this evidence, your Company offers
a wide range of vaccines to prevent specific diseases. Your Company’s range of vaccines grew
faster than the overall vaccines market in 2012. Pneumococcal disease remains the leading
cause of infant mortality in the country. Your Company launched Synflorix a pneumococcal
vaccine last year again at an India specific price from the parent’s research pipeline. Synflorix
was very well received by pediatricians and parents alike and achieved a landmark distinction
of being the 1 st brand in the Indian Pharmaceutical Industry to achieve this level of success
in the first year of launch. The other important vaccines which continue to receive increasing
support from the physician community were Cervarix and Rotarix. Your Company continues to
hold its leadership position with a market share of 24.9% (source: IMS MAT NOV12). During
the year your Company was awarded Frost and Sullivan: Paediatricians’ Award for Vaccines
Company of the year.
New products were introduced in the areas of Dermatology, Oncology, Gynaecology and
Respiratory.
Exports recorded a sales turnover of Rs. 19.59 crores comprising both Bulk Drugs and
Formulations. Exports of bulk drugs were to major markets like Japan, France, Jordan, U.K.
and Germany.
(c) Opportunities, risk, concerns and threats
The economic reforms initiated in the last quarter of the year continued, the projections for
the 12 th Five Year Plan envisage increasing total public funding by the Centre and States, plan
and non-plan, on core health from 1.04% of GDP in 2011-12 to 1.87% of GDP by the end
of the 12th Plan. Higher allocation is intended to support more activities in public healthcare
including improving health infrastructure. A major focus would be to expand the reach of
healthcare and to work towards the long term objective of establishing Universal Health
Coverage in the country.
The Indian government has notified the National Pharmaceutical Policy which brought in
significant change in the price control mechanism by introducing market based price control
based on essentiality of a drug against the existing cost based price control. The span of
control has expanded to include all drugs listed in the National List of Essential Medicines
(NLEM), however, the pricing mechanism intends to retain market prices up to a ceiling price
based on simple average of all brands with market share more than 1%. The new pricing
policy is likely to have a business impact on your Company due to the new pricing mechanism
and the expanded NLEM list of drugs.
(d) Research & Development and Regulatory Matters
During the year under review, in order to support the commercial availability of new drugs
that would benefit and improve the quality of life of Indian patients suffering from various
diseases, your Company submitted necessary applications for New Products in India
to the CDSCO (Central Drugs Standard Control Organization), Ministry of Health and Family
Welfare, Government of India. After a thorough review of its applications, your Company has
received approval for some of these products from CDSCO, which will enable timely access
to new and innovative therapeutic options to patients in our country. Additionally, to support
the R&D efforts of GlaxoSmithKline, your Company submitted 2 Clinical Trial applications
to CDSCO. Your Company has been granted approval, based on a diligent review of our
applications made in 2012, to conduct 4 studies in the Indian population through the Clinical
Operations team in India.
Some of the innovator products approved by the regulatory agency in India during the year
under review include a biological oncology product denosumab in-licenced from Amgen
(Xgeva) for the prevention of skeletal related events in patients with advanced malignancies
involving bone, lamotrigine extended release formulation (Lamictal XR), a medicine for