Being complacent in pharma quality: Five minutes to midnight

I recently had the honour of listening to the talk of Dr Yusuf Hamied, Non-Executive Chairman of Cipla who inaugurated the upgraded chemistry department at the Ramnarayan Ruia Autonomous College, Mumbai. It has been renamed as ‘Dr Yusuf Hamied, Dept of Chemistry’. 

He quoted the teaching of Swami Vivekananda, “While knowledge is important its application is even more important”. Looking at the recent incidents in the Indian pharma industry, are we applying our knowledge ethically? Where is the goodwill we earned when the Father of Generics, our own Dr Yusuf Hamied paved the way for generics way back in the year 2001? Nobody can forget how Dr Hamied led efforts to eradicate in the developing world and to give patients life-saving medicines regardless of their ability to pay, The cocktail of AIDS drugs offered low-cost generic versions of antiretroviral drugs (ARVs) at around $1 per day—a groundbreaking move that disrupted traditional pharma pricing. This strategy showcased CIPLA’s corporate responsibility and prioritisation of public health over profit by giving access to essential medicines to one and all. 

Dr Hamied had stated then, “I don’t want to make money off these diseases which cause the whole fabric of society to crumble.” 

What would be the reaction of the same Africans who had benefited through our antiretroviral drugs and praised Cipla? 

While the recent government initiatives are laudable, e.g. incentives such as exemption of basic customs duty on 36 life-saving drugs and concessional for cancer, rare diseases, and chronic illnesses, have we considered proactively instituting additional resources for enforcement to prevent their misuse? True, we are not moral policemen to prevent off-label or illegitimate use, but indulging or encouraging such activities is unpardonable.

Even more shameful is that a BBC World Service sting operation had to reveal the recent incident of the concoction of Narcotics to African nations, by Aveo Pharmaceuticals. Worse, one of the directors, Vinod Sharma was filmed showing off the same dangerous products the BBC found for sale across West Africa. This video is going viral. 

The US FDA publishes a list of debarred individuals on their website. It is time for the ministry to introspect the regulatory oversight and take strict measures to prevent recurrence. We make multi-bagger Bollywood movies accusing our neighbours. Have we looked in the mirror ourselves or are we turning a blind eye to this incident? How many times are we going to only react: The Gambia cough syrup incident is not very old. 

As we know, after this incident was brought to light, The Central Drugs Standard Control Organisation (CDSCO) and the State FDA banned the production and export of combination drugs containing Tapentadol and Carisoprodol, which were found to be misused in West African nations. The Centre and State regulators are still pointing fingers at each other stating their limits of jurisdiction, for this apparent ‘miss’. 

Where were our enforcement officers? Do we need more human resources or do we need to build efficiency or do we need ‘Musks’ to challenge their efficiency? Out of the box thinking is required ASAP now. 

Can we deploy defence forces to support the raids? Can we hire experienced independent auditors and deploy them to conduct surprise audits? 

Another big issue is already gazing at us: the recent re-introduction of the PILLS Act by Congresswoman Tenney. This bill offers tax incentives to pharma companies to shift manufacturing processes, including materials and testing, to the United States. So, what is the effect on our ‘Make in India’ scheme? 

It is time for CDSCO to pull up their sleeves, engage pharma leaders on deputation or projects and just conduct random surprise inspections. We have to wake up. We have once again showcased to the world something that we should be ashamed of. 

While we talk about the digital era and mechanisms to reduce personnel, can digital leaders help in finding such criminal drug activities and nip them at the root? If yes, it is time to ACT NOW. 

We all talk about quality culture, technology advancements, and patient-centric approach. Advanced data analytics and skilled talent will drive the next phase of growth in India’s pharma industry. We preach that quality is everybody’s responsibility; unfortunately, we have proven by example that it is nobody’s. 

It is now past a wake-up call for leaders – Both regulators and industry to start thinking about how to improve our severely tarnished image in the pharma sector. 

“The key to everything is patience. You get the chicken by hatching the egg, not by smashing it.” – Arnold H. Glasow 

The above proverb will not work for us. It has to be exactly the opposite. 

It takes years to build an image and seconds to break it!