By Sanjeev Gupta
Kusum Group of Companies
If not that rampantly in the developed countries, but definitely in the developing countries, and especially in India, access to medicines comes first, even earlier than the access to healthcare facilities or doctors. This essentially means that come illness, most likely one would swallow a pill first and then visit a doctor, if at all felt necessary.
In a state where consumption of medicines takes such precedence, the quality standard of drugs need to be the primary focus area for the pharmaceutical industry. Not that the industry encourages the unregulated consumer habits of purchasing over the counter drugs, but the onus of manufacturing high quality medicines with fewer adverse effects has to be the borne by the pharmaceutical industry.
When composing a medicinal drug, the most important considerations invariably are identity and purity. The slightest deviations from the set norms complied by the originator can be damaging to masses, if the same goes unchecked during the research and development process. The creation and accessibility of comprehensive pharmacopoeias themselves is a matter of much care and complexity. It is of the wider public knowledge and understanding that export quality of products nonexclusive to pharmaceutical drugs is different to what is either imported or sold internally. In products as essential as medicines, it becomes all the more important to evaluate the quality standards of the drugs exported to those being sold to one’s own citizens.
Quality Standard of Drugs: Brief Context
It is estimated that 70% of pharmaceutical drugs in India is generic, with 9% being oriented and 21% being over the counter drugs. The entire generic drug industry is estimated to be of around US$ 30 billion.
The pharmaceutical industry is much export oriented; however in recent years, various factors contributed to an export slump, with export figures dropping from US$ 6488 million in 2015 to US$ 2082 million in 2016.
The dropping of export figures is reflective of the various challenges faced by the industry in re-establishing the Indian pharma brand and culture as one which is quality oriented. In the otherwise flourishing and growing industry, quality standard of drugs remains the major burning area.
India has remained the largest supplier of pharmaceutical drugs to United States. Till last year, US Food and Drug Administration (FDA) had sent 42 warning letters to its global manufacturers of drugs. Nine of those letters were directed towards Indian facilities. In light of repeated concerns, US FDA inspection in India has increased by over 20%.
While the other developing countries including CIS (Russian Commonwealth) nations, Latin American nations, African Countries have favored India for importing pharma products, keeping the immediate competitor, China, fairly behind; it is only fair that the reputation gained of being a quality affordable drugs provider be sustained with consistent quality delivery, even though the quality assessment procedures in these countries may not be as rigid as US FDA.
Challenges and Solutions
It will only be beneficial to the credibility of the industry in the longer run if the challenges are identified and a roadmap be worked upon to address these issues in a time bound manner. Some of the common challenges that have been ailing the industry include
Low Government investment in healthcare. The government investment in healthcare is still shying away to touch the 2% GDP mark, which is not only affecting the hospital industry but the pharma industry as well. A 1 to 2 per cent increase of investment in healthcare, and perhaps a minimum dedicated investment for pharmaceutical industry, will give the industry the required boost to strengthen its manufacturing output and upgrade the quality standards across the board.
Ensuring better level playing field. The existing focus has been on promoting low-scale indigenous manufacturing enterprises to push unbranded generic medicines at a much cheaper rate. While the same may seem beneficial for the poorer masses, the same should be allowed only when the domestic entities match the quality and uniform standards those that export to a global consumers. Lower quality standard is not only detrimental to the credibility of the industry at large but also to the health of the nation. A robust quality framework for domestic markets also helps in creating larger and better global impression of Indian pharmaceutical industry as a reliable player, as exporters necessarily face higher quality compliance requirements to maintain export competitiveness and international credibility. Regulatory authorities such as the Central Drugs Standards Control Organization (CDSCO) should be empowered more to ensure the compliance of established law.
Another important benefit of ensuring level playing field is that Indian population has been suffering from long with lower standard cheap drugs with reduced or no efficacy. It is only right that the best quality products is made available first to the nation and then be exported elsewhere. This will also help offshore companies to invest heavily in India, noting the volume that India drives.
Limit the range of medicines that are subject to price control. Research and development, coupled with the complete manufacturing process, and added quality checking mechanisms such as pharma covigilance is a high manufacturing cost of the final product. Extending the number of medicines, which is now 20% of drugs by sales volume, that are subjected to price control will adversely affect the production of quality products in order to maintain sustainability. High margin combination drugs will also suffer from this.
Ensuring efficacy of Indian manufactured drugs, data integrity, and hygiene factors. These three form one of the strong pillars for ensuring quality standards in Indian drugs. Stronger guidelines for manufacturing drugs, due diligence in maintaining data integrity, and implementation of strong hygiene policy from the time of importing of raw materials to the time of packaging and finalizing batch for sales, are essential elements to ensure quality standard.
The Good News
The government has recently provided much hope and positivity to the entire industry and the world by initiating the drafting of Pharmaceutical Policy 2017, which gives significant focus on the quality concerns challenging the industry today. The draft is yet to mature, but the same will happen when the industry leaders across the board, policy makers, healthcare experts, government, domestic and private players, all come on board to engage and debate severely in order to resolve the quality challenges of the industry. Recently, the announcement by Drug Controller General of India (DCGI) to start the single window facility for providing consent, approvals, and other information will further ease the process for Indian manufacturers, allowing them to focus their energy on other matters. Digital integration of pharmacies will not only ease the flow of drugs with a proper track from one point to another but also help regulate pharmacies.
More initiatives are required at a quicker pace for India to dominate pharma industries of the world, as countries like China are closing on our heels with many aggressive measures.