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Some of the innovator products approved by the regulatory agency in India during the year
under review include a biological oncology product panitumumab in-licenced from Amgen
(Vectibix) for the treatment of patients of metastatic colorectal carcinoma as third line treatment
option, a line extension for amoxicillin and clavulanic acid formulation (Augmentin Drops)
for paediatric use, expansion of use of DTaP vaccine (Boostrix) for use in adults and new
indication for the use of cefixime formulation (Cefspan) in enteric fever. All these new products
approved for the Company during the year under review will be beneficial to Indian patients.
In addition, the Company also received approval for import and marketing of 7 cosmetic
products in India.
GlaxoSmithKline globally continues to be committed to Research and Development of
medicines that will improve the quality of life of people around the world and truly make a
difference to patients. Our scientists work hard to discover new medicines that prevent, treat
or cure diseases.
Your Company conducted studies in oncology, anti-infectives and osteoporosis, after
obtaining necessary Ethics Committee and regulatory approvals. Your Company has trained
42 new investigators on Good Clinical Practices and protocol-related science at approximately
40 clinical trial sites across India. Quality continues to be a priority as demonstrated by a
number of internal and external compliance audits with no critical findings. To strengthen quality
of data, quality checks are meticulously reviewed, systems and processes are simplified to
ensure compliance to regulations. This will help generate accurate and meaningful data, and
ensure that the rights, dignity and safety of patients taking part in our studies are protected.
The Medical Affairs team has provided valuable medical inputs for the development and
execution of launch strategy for several products including Avamys (fluticasone furoate),
Xgeva (denosumab), Cardio Check, Physiogel and Acne-aid wash. The team played a
crucial role in communicating high-quality scientific information to the medical fraternity. It
was involved in conducting scientific engagement activities such as advisory board meetings,
congress presentations, publications, satellite symposia and provision of evidence-based
medical information to healthcare practitioners. The Medical Affairs team and the Medical
Governance teams ensure that your Company’s promotional activities and HCP (healthcare
practitioner) engagements are in line with all the applicable guidelines and standard
operating practices.
(e) Internal Control Framework
Your Company conducts its business with integrity and high standards of ethical behaviour,
and in compliance with the laws and regulations that govern its business. Your Company
has a well-established framework of internal controls in operation, supported by standard
operating procedures, policies and guidelines, including suitable monitoring procedures and
self-assessment exercises. In addition to external audit, the financial and operating controls of
your Company at various locations are reviewed by the Internal Auditors, who report significant
findings to the Audit Committee of the Board. Compliance with laws and regulations is also
monitored.
Your Company’s Code of Conduct sets out the fundamental standards to be followed by
employees in their everyday actions. In accordance with the Code of Conduct, and Standards
associated with the Code of Conduct, employees are required to become familiar with the
legal requirements, policies and procedures applicable to their areas of operation, avoid
conflicts of interest and are tasked with upward reporting of all unethical and illegal conduct.
All employees are committed to the principle of performance with integrity and ensuring that
activities comply with all applicable laws.
Additionally, employees are required to certify on an annual basis whether there have been any
transactions which are fraudulent, illegal or violative of the Code of Conduct. Strong oversight
and self monitoring policies and procedures demonstrate your Company’s commitment to the
highest standards of integrity.
Your Company’s policies and updated Global Code of Practice for Promotion and Customer
Interactions prescribe the nature of practices and prohibits specifically those which are
unethical. Your Company is a signatory to the OPPI (Organisation of Pharmaceuticals
Producers in India) Code of marketing conduct. Your Company is also governed by the anti-
bribery and corruption programme which is applicable across the global organisation and
complies with the principles laid down under US Foreign Corrupt Practices Act and British
anti-bribery laws.
