Quality standards of drugs have to be the primary focus area of pharma
India is struggling with a host of communicable and non-communicable diseases, and with this the importance of medicines has increased. With changes in lifestyle and a high-paced life, one can see people buying medicines over the counter (OTC) without prescription and consuming them at will.
In a state where consumption of medicines takes such precedence, the quality standard of drugs needs to be the primary focus area for the pharmaceutical industry. Not that the industry encourages unregulated consumer habits of purchasing OTC 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. Even the slightest of deviations from set norms complied by the originator can be damaging to the masses, if the same goes through unchecked during the research and development process. In products as essential as medicines, it becomes all the more important to evaluate quality standards.
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 is 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 pharmaceutical industry as well. A 1-2% increase in investment in healthcare, and perhaps a minimum dedicated investment for the pharmaceutical industry, will give the industry the required boost to strengthen its manufacturing output and upgrade quality standards across the board.
—Ensuring a level-playing field: The existing focus has been on promoting low-scale, indigenous manufacturing enterprises, to push unbranded generic medicines at a cheaper rate. While the same may seem beneficial for the poor, it should be allowed only when domestic entities match quality standards with the medicines exported to other countries. Low quality is not only detrimental to the credibility of the industry at large, but also to the health of the nation. Regulatory authorities such as the CDSCO should be empowered to ensure compliance.
—Limit the range of medicines that are subject to price control: Research and development, coupled with the entire manufacturing process, and added quality checking mechanisms such as pharmacovigilance, all add to manufacturing cost. Extending the number of medicines subjected to price control will adversely affect the production of quality products, in order to maintain sustainability.
—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 finalising batches for sales, are essential elements to ensure quality standards.
The good news
The government has recently provided much hope and positivity to the industry, and the world, by initiating the draft Pharmaceutical Policy 2017, which lays significant focus on the quality concerns challenging the industry. Also, the announcement by the 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 energies on other matters. Digital integration of pharmacies will not only ease the flow of drugs with a proper track record from one point to another, but also help regulate pharmacies. More such initiatives are required, and at a fast pace, for India to dominate the global pharmaceutical industry, as countries like China are closing on our heels with aggressive measures.
The Author is Managing Director, Kusum Group of Companies