An under-repair entrance reveals a narrow staircase that leads into a quiet room where men and women sit bent over their work. The wall on one side is stacked with specially-designed boxes to ship medicines that are not easily available to not easily accessible regions.

“We supply to countries where no one wants to do business,” says Dr Piyush Gupta, founder of GNH India, referring to supplies to strife-torn or sanction-ridden countries, including Somalia, North Korea, Venezuela and Libya. “We are WHO GDP (Good Distribution Practices) certified,” he says. This paves the way to supply the United Nation’s multiple agencies that operate in challenging regions.

Founded in 2003, GNH’s operations truly got under way in 2008, says Gupta, a trained doctor who worked with a couple of pharmaceutical companies since he was so inclined. The company decided to focus on addressing shortages that exist in different countries, given the gaps in the pharma trade cycle. So, besides supplying challenging markets, GNH also imports critical medicines for patient treatment, orphan drugs and reference drugs for clinical trials involving comparative studies of medicines.

A wholesaler by definition, GNH sets itself apart by offering a systematic and professional service, says Gupta and having a GDP certification is a big part of that exercise.

Reputation concerns

Explaining further the decision to narrow focus to short-supply drugs, Gupta says many companies sit on “dead registrations”. And that’s because the business literally changes in the time between registering a drug in a market and getting the approval to actually sell it there.

The other challenge in the international arena involved reputation, where Indian companies come up short because of quality, bad management, batch recalls, etc. It’s not just the company, but the image of the industry and country that get “dented,” he says, when a substandard drug is sourced back to India.

Recalling his business development experiences, he says patients in CIS countries asked for English or Turkish medicine and only then came “Industani” medicines. Companies and distributors need to build trust by being compliant with Current Good Manufacturing Practice (cGMP) norms or GDP norms, he says, adding that everyone has a responsibility. “You have to keep your end of the deal.”

But sometimes cumbersome rules also make it difficult to comply, he says. Importing a cancer drug for a patient involves, among other things, “four types of declaration on ₹500 stamped paper. When the patient is already suffering from cancer what more do you want?” he says, calling for simpler processes for patient/doctor identification and registration details. “There is an endless compliance burden on companies,” he says, adding that three of his employees work on growing the business while 10 are dedicated to regulatory compliance. Rules need to be stringent, but simple, he says. Otherwise, Indian companies could lose out to competition, as much time, energy and money get invested in meaningless regulatory pursuits.

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