Drugmakers must adopt adopt world-class manufacturing practices and operate in ethical manner
The recent meeting saw the government, regulators, captains of the pharmaceutical industry, pharma associations and healthcare professionals from across the country converged on one platform.
The theme ‘Make, Develop and Innovate in India’ generated animated discussion around what India needed to truly become a ‘Pharmacy to the World’.
The conclusion was unanimous and all the stakeholders agreed that if intent is to become action, then the time is now! The need of the hour is a collaborative approach that will ensure patients’ access to innovative medicines while supporting the government’s goals of bringing growth to India through research, innovation and manufacturing.
While India has made rapid strides in economic growth and lifted millions out of poverty, progress in improving health outcomes has been slow. In its recent assessment of the Indian economy, the Organisation for Economic Cooperation and Development (OECD) identified India’s poor health outcomes as one of our major developmental challenges.
We are hopeful that the government will prioritise healthcare, strengthen infrastructure and focus on skill development. The government must increase healthcare budgets from the current 1 to at least 2.5 per cent in the next two years. Access to healthcare extends beyond the cost of medicine, to the proximity, quality and functionality of the infrastructure that supports that access.
More than affordability, the barrier to access is the inability to pay out-of-pocket and the lack of insurance cover. Implementing the promised Universal Health Assurance programme will help benefit patients and increase access.
Creating a healthy India requires balancing the need for innovation with the necessity for more affordable medicines, within a robust IP environment. Pro-innovation policies and increased access to medicines are not mutually exclusive, but must go hand-in-hand for the benefit of patients.
Research cannot be allowed to stop! India should favour an innovative environment that supports research and development of new medicines, within India and around the globe. Patent protection is necessary for continued investments in innovative life-saving drugs. Innovation and patenting processes together form the key elements of a modern, self-confident economy.
Quality is another big concern. Patients need to be assured that their medicines conform to prescribed standards and that manufacturers adopt world-class manufacturing practices and operate in an ethical business environment.
We constantly read about the recalls and bans of sub-standard drugs from the US and European markets. We can no longer ignore the urgent need for stringent and non-negotiable quality framework. The pharmaceutical industry must focus not only on manufacturing the latest medicines, but on establishing and ensuring adherence to the highest quality standards for every drug sold.
Collective responsibility
The healthcare industry has a collective responsibility towards all patients and must guarantee that we deliver ‘responsible healthcare’. This can happen only when our entire healthcare eco system complies with global good manufacturing practices and stringent ethics codes.
The government’s declaration of its Uniform Code of Pharmaceuticals Marketing Practices (UCPMP) becoming a formal code, effective January 1, 2015, is a very welcome move. India is a critical market in the global pharmaceutical ecosystem.
A number of factors put India in a strong position to become a leading global innovator of new medicines, within an environment that rewards innovation. We have much to be proud of: the Indian pharmaceutical industry is the third largest in the world by volume; it is the second highest foreign exchange earner in the world; and it is a generics powerhouse.
Drug development is really the cutting edge of pharmaceuticals and here we have very little to show. The reasons for this are complex, but we will certainly go far in realising our potential to be a global leader in R&D if we are able to ensure a robust protection of intellectual property.
If we are able to protect our innovators and creators, we will create and attract world class R&D as well as create and sustain high quality jobs. This will help take us closer to the stated objective of ‘Make, Develop and Innovate in India’ and closer to attaining our goal of turning India into one of the world’s leading destinations for end-to-end drug discovery and innovation by 2020.
Any long-term solution to India’s healthcare challenges will require a holistic approach and a critical evaluation of our existing systems. The industry is more than willing to support the government and help address the nation’s healthcare challenges. The time is right, the time is now!
(The writer is Director General, Organisation of Pharmaceutical Producers of India
