Pharma Focus Asia
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Why Quality Standards of Drugs has to be the Primary Focus Area for Pharmaceutical Industry

Sanjeev Gupta, Managing Director, Kusum Group of Companies

Time and again, Indian pharmaceutical industry has faced concerns due to its manufacturing standards and quality, which have led to penalties and drops in export figures. For the industry to realise its potential to capture world markets, the primary focus has to be towards improving quality standards to international levels.


Perhaps not as 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 deemed necessary

With consumption of medicine taking precedence, the quality 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 borne by the industry.

When composing a medicinal drug, the most important considerations invariably are identity and purity. The slightest deviations from the set norms by the originator can be damaging to masses, if the same goes unchecked during research and development. 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 non-exclusive to pharmaceutical drugs is different to what is either imported or sold domestically. 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 Standards of Drugs: Brief Context

It is estimated that 70 per cent of pharmaceutical drugs in India is generic, with 9 per cent being oriented and 21 per cent being over the counter drugs. The entire generic drug industry is estimated to be of around US$30 billion.

The pharmaceutical industry is very export-oriented; however, in recent years, various factors have contributed to an export slump, with export figures dropping from US$6,488 million in 2015 to US$2,082 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 an otherwise flourishing and growing industry, the quality standards of drugs remains a hot area.

India remains the largest supplier of pharmaceutical drugs to the United States. Until last year, US Food and Drug Administration (FDA) had sent 42 warning letters to its global manufacturers of drugs, nine of which were directed towards Indian facilities. In light of repeated concerns, FDA inspections in India have increased by over 20 per cent.

While other developing countries including, CIS (Russian Commonwealth) nations, Latin American nations, African countries have favoured India for importing pharma products,—keeping the immediate competitor, China, fairly behind—it is only fair that the reputation 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 the US.

Challenges and Solutions

To maintain the credibility of the industry in the long run,it is important that challenges are identified and a roadmap is worked upon to address them in a timebound 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 per cent of the GDP, 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 a 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, it should be allowed only when the domestic entities match the quality and uniform standards of those that export to a global consumers. Lower quality standards 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 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 to ensure the compliance of established law.

Another important benefit of ensuring a level playing field is that Indian population has been suffering for long due to lower standard cheap drugs that have reduced or no efficacy. It is only right that the best quality product is made available first to the nation and then 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 a complete manufacturing process, and added quality checking mechanisms such as pharmacovigilance adds to the manufacturing cost of the final product. Extending the number of medicines, which is now 20 per cent 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

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.

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 provides significant focus to the quality concerns challenging the industry today. The draft is yet to mature, but it will only 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. The announcement by Drug Controller General of India’s (DCGI)to start a 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.

With the launch of latest government policy, small and medium scale pharma companies will get interest-free loans of upto five crores to upgrade their infrastructure and technology. The interest will be borne by the government. However, the pharma companies have to obtain World Health Organization / Good Manufacturing Practices (WHO/GMP) certification within three years of disbursement of the loan.

Moves like this will go a long way in improving the image of Indian pharma industry worldwide. What this step is essentially doing is to encourage the around 250 small and medium level pharma enterprises with a budget of Rs.144 crore for 2018-2020 to upgrade the quality of products to international standards.

This will expand international markets from developing countries to developed countries of Europe and the USA. It will not only boost our economy but also will improve the standing of the pharmaceutical industry of India.

India should advance to become a Pharmaceutical Inspection Co-operation Scheme (PIC/S) member, which is a non-binding, informal cooperative arrangement between regulatory authorities in the field of GMP. This is to ensure common standards of drugs manufacturing across the member countries. Today, smaller economies like Thailand, Malaysia, Indonesia, Iran, Turkey, and Ukraine are part of the PIC/S group while India is falling behind.

India has a huge potential for manufacturing pharmaceutical products thanks to massive manpower and advanced technology, and can become a world leader in producing high quality medicines at relatively economical cost.

For this to happen, as an industry we need to show intent to grow internationally. More initiatives are required at a quicker pace for India to dominate
the world, as countries like China are closing in on us with aggressive moves.

The government is making its decisions but policy making also depends on how the industry creates advocacy for a common objective. Quality of drugs needs to be the primary focus for the next decade, and it is only by ensuring quality that India can grow further. It is important to understand that the efforts of the pharmaceutical industry has a direct impact on lives worldwide and it is the primary reason why we need to be one of the most responsible stakeholder in ensuring national health.

--Issue 32--

Author Bio

Sanjeev Gupta

Inculcating the very persevering values of rigor, ambition and discipline in all his endeavours, Sanjeev Gupta is the man responsible for the success of the Kusum Group of Companies. In a sea of upbeat entrepreneurs, Sanjeev stands tall as a veteran in the pharmaceutical industry with over 30 years of experience.

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