Recently I read an article about how India was set to overtake China as the generics capital of the world. Not because of better numbers but because Chinese pharma companies are now increasingly investing in research and development to bring new and innovative therapies to market. We're getting the spot not because we're overtaking China but because China is abdicating.
Our pharma industry still has a long way to go before we lead. So I'll just come right out and say there are three weak links in our pharma system. The first is Education, the second Regulation, and the third is production. Let me explain why.
I was once invited to speak at a conference in Hyderabad. The organisers arranged for me to be picked up at the airport. They sent along a student (of the local Pharmacy College) whose only job was to be my shadow and ensure that I had a smooth stay.
On my way back to the airport the next day, I initiated (or tried to) a conversation with him. The young fellow was doing his M. Pharm. He didn't speak much English, but I gathered that he was heading to his village to 'practice' after his degree! I was intrigued. He explained, as if to a limited person - practice medicine! He said his father had worked as a compounder and now practised as a Doctor! And since he was far more knowledgeable as a pharmacy major, he was better equipped to practice!
How many fake doctors and practitioners of medicine do we have in our interiors. In their 2016 report, the WHO said that 57.3% of all the doctors in India are quacks - they operate without a medical degree. Then Union Health Minister JP Nadda quickly dissed the report as erroneous, but now Union Health Ministry is admitting it to be true. And, it's not surprising that most of them are found in rural pockets of the country.
One of the resultant outcomes of the indiscriminate prescriptions or of consumption of antimicrobials before any tests to determine their necessity is what is known as AMR or antimicrobial resistance! This is a significant health problem in our country and globally in BRIC and African countries. Emerging resistance to treatments for other diseases, such as TB, malaria and HIV, have enormous impacts in lower-income settings. The growing prevalence of drug-resistant strains of TB is well documented: there were an estimated 480,000 new cases in 2013 - of which the majority went untreated.
It has been estimated that if no action is taken against AMR, it will be the leading cause of death, with 10 million victims per year by 2050.
In India, the CDSCO puts out rules from time to time that applies to the production, distribution and sale of prescription medicines. In the Pharmacy Act 1948, which regulates the operation of pharmacies, exists a provision that a registered Pharmacist must be present on all such premises. Very rarely do you find one present at all times in our local pharmacies. As far back as Jan 21, 2014, our Pharmacists wanted CDSCO to clear ambiguities in the D&C Act to enable better pharmacy practice.
No other country in the world has the regulatory dichotomy as we do in India - Union vs States.
Clinical trials, new drug approvals and post-marketing surveillance are all under the purview of CDSCO, the central authority, while production, distribution and sales are all under State Drug Regulatory Authorities (SDRAs). Not all States are equipped to the same degree of efficiency or have adequate resources to control and oversee pharma production and sales. This results in some states taking years longer than others to implement the same rules leading to confusion.
Size does not guarantee Good Manufacturing Practice (GMP). Katherine Eban's book Bottle of Lies tells all about Ranbaxy India, then India's largest pharma company. If you haven't read this book, please do. As she tells it in the book, India's top pharma company, in both size and prestige, had to be sold off in distress due to non-compliance in many areas of production.
In India, we have units from very small to multinational in scale. Several of these small-scale production units that operate as production units for larger companies under a loan license (or contract manufacturing) are blissfully unaware of all the requirements of GMP. Loan licensing is a uniquely Indian peculiarity where the manufacturing license is loaned to another company that makes the original company's product. Many Indian pharma manufacturers have yet to fully grasp that testing and finding that the product passes all respects is not enough. Our CDSCO has an extensive section devoted to GMP; unfortunately, much is on paper than in practice. As a lecturer in many forums my favourite example was that if you tested idli from a professional commercial kitchen and one from a street stall, both might comply with all tests. However, the facility in which they are made and cleanliness also matter.
Until our educational, regulatory and manufacturing environment are brought up to par, India faces significant challenges if it is to lead the pharma evolution. The global pharmaceutical market is evolving rapidly. For Indian companies willing to invest in training and upskilling, GMP and manufacturing innovation, there are big rewards to be had.