“Gujarat has the lion’s share when it comes to exports in India, with 28% of all pharma exports leaving from the shores of our state. With over 700 WHO-certified production facilities, drugs made in Gujarat are authorized to sell around the world. More than half of our exports actually reach the highly regulated markets like the US and Europe.”
Could you outline the key characteristics that have earned Gujarat the title of “pharma capital” in India?
Geographically, Gujarat only covers about 6% of the country’s area, but it represents a third of all pharmaceutical production. Relying on a strong heritage of over 100 years of drug production matched with an excellent track record for quality, today we take pride in being a central hub in the country and the world. Almost all medical devices, half of India’s intraocular lens (IOL), and 35% of the country’s diagnostics kits are made in this relatively small state. Gujarat is also home to 40% of all CRAMS (Contract Research and Manufacturing Services). Finally, we are the largest producer of contraceptive pills globally, supplying to over 60 countries. Not surprisingly, Gujarat has the highest pharmaceuticals turnover in the country.
Overall, there are 4,766 licensed manufacturers in Gujarat, of which 3,000 are producers of allopathic medicines, 866 dedicated to traditional medicines (primarily Ayurveda), 527 work on cosmetic products, and nine are homeopathic drug manufacturers. Out of these, almost 700 are WHO-GMP compliant.
What is the role played by FDCA Gujarat and how is this being accomplished?
The mandate of FDCA (Food and Drugs Control Administration) is to ensure the safety and quality of allopathic, homeopathic and traditional medicines, as well as the safety and efficiency of medical devices, blood banks, blood storage centers and diagnostics tools. These tasks are realized through a licensing system for both manufacturing and pharmacies, together with routine inspections executed periodically.
Over the years, FDCA Gujarat achieved national recognition for implementing modern and sophisticated technological tools to increase effectiveness. Our e-governance system connects producers and sellers, and the pioneering software has been recognized with the national award for e-governance –Gold Award, and has been subsequently adopted by 19 other Indian states.
Moreover, we brought in a mobile drug-testing lab operated with a handle device so that, in a fraction of time, we can detect the quality of the product without having to remove the container. In an effort to maximize our efficiency and eliminate all risks, FDCA Gujarat is the only regulator to have acquired a microbial contamination testing system from Lyon-based BioMérieux. Using this system, we can test product sterility in three to four hours, while the standard procedure would take days to complete.
What is the product range of most prominence in Gujarat, and how has this evolved?
Gujarat’s core competence is in formulations, with 60% of our product output consisting of finished dosage forms (FDF). However, more than simple generics formulations, Gujarat also has high-tech units with a wide range of therapeutic products like interferon, monoclonal antibodies, genomics, proteomics, and products with novel delivery systems (DDS) like dermal patches and inhalation devices. The world's first biosimilar monoclonal antibody was created in Gujarat and, in keeping up with this legacy, four companies based in our state are actively engaged in the research of repurposing existing medicines-like Hydroxychloroquine and antiviral drugs for the treatment of Covid-19. The industry is very keen to meet global challenges and safeguard public health.
How do Gujarat-made drugs fare in international markets?
Gujarat has the lion’s share when it comes to exports in India, with 28% of all pharma exports leaving from the shores of our state. With over 700 WHO-certified production facilities, drugs made in Gujarat are authorized to sell around the world. More than half of our exports actually reach the highly regulated markets like the US and Europe. 130 facilities are approved by US FDA, and the FDCA maintains a close relationship with the US-delegate regulator, exchanging information and ideas to ensure best practices and ultimately make sure that products made in Gujarat meet the highest standards.
The coronavirus pandemic has disrupted manufacturing around the world. How have pharmaceutical businesses in Gujarat navigated these challenges?
India imports about 65% of its basic chemicals, intermediates and APIs from China, therefore the lockdown in China naturally hindered operations here. Coupled with the subsequent lockdown in India, the challenges were vast. March and April were particularly difficult, halting production by 70% compared to the same period last year. Thankfully, we were able to resume work and Gujarat companies now operate at 80% capacity. It is crucial that citizens must not suffer from shortages of essential medicines; in this aim, the central government has made available special cargo flights to meet the needs of the 1.3 billion people of India.
What makes Gujarat an attractive destination for investors?
Gujarat benefits not only from good governance and a lack of bottlenecks and red tape, but also excellent infrastructure, from a power supply surplus, high-speed internet connectivity, gas pipeline infrastructure, as well as great transportation, with almost 65% of all Indian cargo entering through Gujarat thanks to our 600km coastline.
Besides, the government recently proposed two industrial parks in Gujarat: one medical devices park and one bulk drug (API) park, which have already received the most important approvals. The areas have already been earmarked; one in Ankleshwar, where the API industry is currently very vibrant, and another one in Rajkot, for the medical devices. In these parks the government will fund the construction of common facilities, from warehouses to testing labs, which will help manufacturers reduce costs and increase their competitiveness in the global markets. These new parks will help the industry shine further.