Antonina Antosha has never vaccinated her 6-year-old daughter.
There are many reasons why, including the lack of proper screenings and general distrust in Ukraine’s healthcare system. But Antosha’s biggest argument is the vaccines’ origin.
“They could come from India,” she said. “You don’t know what kind of conditions they’ve been in and how well they’ve been stored.”
Her position isn’t unique. Distrust in vaccines is a longstanding issue in Ukraine. Only half of the population believes they work, according to the latest British Wellcome Trust report.
Indeed, there is a high chance that a vaccine offered in Ukraine was produced in India. Ukraine imported $146 million in Indian-made pharmaceuticals in 2019 alone, making it the second-biggest drug supplier in Ukraine’s $2.8-billion pharma industry after Germany.
However, there is no reason to believe that Indian vaccines — or any other vaccines sold in Ukraine — are of poor quality and can be dangerous, virtually all pharmaceutical companies in the country say. On the contrary, vaccines and other drugs have never been safer because of strict compliance with Western standards established by the United States and the European Union.
But people still prefer to keep themselves and their children vaccine-free. And in recent years, this rigid stance has led to deaths. Since 2017, measles has infected 115,000 Ukrainians and killed 41 of them, 25 of whom were children, according to the United Nations Children’s Fund, or UNICEF.
And while Indian pharmaceutical companies are increasing their sales in Ukraine, they need to face this challenge: to prove their drugs are safe and necessary to save lives.
Ramanan Unni Parambath Menon, the president of the Indian Pharmaceutical Manufacturers Association, talks to the Kyiv Post in central Kyiv on Jan. 20, 2020. The IPMA makes sure every pharmaceutical company on the market meets the strictest certifications in Ukraine and abroad. Ukraine imported $146 million in Indian-made pharmaceuticals in 2019 alone, making it the second biggest drug supplier in Ukraine’s $2.8-billion pharma industry after Germany. (Kostyantyn Chernichkin)
Safer than ever
In 2019, India was reportedly the largest provider of generic drugs in the world and it produces 60% of vaccines worldwide, which makes it a bigger player than all other countries combined.
And in Ukraine, Indian drug manufacturing is expanding: about 4,000 drug brands from over 860 manufacturers were registered in the country in 2019, including 36 new brands from Indian pharmaceutical companies that are actively increasing their sales here.
Most recently, the Odesa city council announced that India’s Spectrum Pharmatech Consultants plans to build a factory and a development center in Odesa.
The Indian Pharmaceutical Manufacturers Association, or IPMA, which has been active for a decade in Ukraine, advocates for Indian pharma manufacturers. It unites 11 leading Indian companies operating in Ukraine, including global brands like Dr. Reddy’s and Ranbaxy.
The companies belonging to IPMA must have offices in Ukraine and comply with international quality standards, the association’s president, Ramanan Unni Parambath Menon told the Kyiv Post.
The purpose of the association is to promote the provision of safe, effective and affordable medicines to Ukrainian citizens. Every company belonging to the IPMA must obtain a World Health Organization certification, known as Good Manufacturing Practice, or GMP.
“If someone thinks that cheap medicines are bad medicines, that is a wrong concept,” Menon said. “We are the cream of the Indian industries.”
Menon claims that the IPMA makes sure every company meets the strictest certifications worldwide, including those by the U. S. Food and Drug Administration, the U.K.’s Medicines and Healthcare products Regulatory Agency among others.
He also insists that, if Indian companies do not meet the norms of Western GMPs, they won’t have access to the IPMA and, thus, cannot operate on the Ukrainian market.
Sanjeev Bhagat, the president of pharma company EuroLifecare, confirms Menon’s claim. He notes that Ukraine has moved closer to European Union’s regulatory system.
Registered in London in 2002, his company is part of the IPMA and has operated in Ukraine since 2009.
Both Bhagat and Menon believe that the statistics on Indian companies’ global success speak volumes about the quality of the medicines they produce. Fulfilling over 50% of global demand for vaccines and 40% of demand for generics in the U.S., as well as providing 25% of medicines in the U.K., the industry has to be safe for consumers.
Both men argue that drugs and vaccines passing tests in the U.S. and the U.K. and distributed by UNICEF are fit for Ukraine too — patients shouldn’t worry about using them.
“We have quality products, and I can vouch for all the IPMA members,” Bhagat said.
India’s reputation
If there is a problem with Indian drugs, it is likely caused in Ukraine.
IPMA’s Menon says Kyiv must also improve its regulations to ensure drug safety.
Indian pharmaceutical manufacturers and Ukraine’s healthcare system are two separate entities, and Menon admitted that IPMA companies can hardly control what is happening to the drugs after they are delivered.
Ultimately, storage, preservation and transportation conditions are the responsibility of the Ukrainian government. These issues should be addressed on a local level, he said.
A lack of transparency an excessive bureaucracy in Ukraine are also problems. They allow the smuggling of low-quality medicines, falsely labeled as Indian, to flood the market and tarnish the reputation of Indian firms, Menon said.
In 2011, the Ukrainian parliament voted unanimously in favor of new legislation to criminalize the production and trafficking of counterfeit drugs. Yet authorities still struggle to fight this dangerous illegal enterprise.
In January 2020, the Security Service of Ukraine, or SBU, dismantled a large-scale underground production facility in Kharkiv Oblast, where counterfeit medicines were produced and then sold online to customers in Kyiv, Odesa, and Lviv.
On May 31, 2019, the Ukrainian State Border Guard Service and police officials raided 11 underground manufacturers in Kyiv and seized counterfeit medicines estimated to be worth tens of thousands of euros.
To tackle this issue, Menon called for more traceability, pushing Ukraine to place bar codes on medicines as India did four years ago.
“There are foul players on the market, and local bodies should reply to why they are allowing this contraband,” Bhagat said. He believes healthcare system corruption endangers Ukraine’s wellbeing.
In 2015, then-Health Minister Ulana Suprun started a four-year program to outsource drug procurement to international organizations, including UNICEF and the United Nations Development Program.
The goal was to root out longstanding corruption in the country’s drug procurement process. Previously, politicians, ministry bureaucrats and pharmaceutical distributors worked together to inflate prices.
While giving credit to Suprun’s reforms pushing for greater transparency, Bhagat said hospital purchase systems are still abused.
A draft law passed by the new parliament, controlled by Ukrainian President Volodymyr Zelensky’s Servant of the People party in September 2019 could effectively end the ministry’s ability to rely on international organizations like UNICEF starting in mid‑2020 — then, drug procurement will have to be carried out independently by Ukraine.
Bhagat is cautious about Zelensky’s plan to come back to a donors-free system, he sees it as a step backward.
“All the people that were working under (ex-President Viktor) Yanukovych are back,” he said. He doubts that new people will have the expertise to conduct proper drug tenders.
“If Zelensky cannot provide at least a corruption-free healthcare system to Ukrainian citizens, he has to pay for that,” Bhagat said.
He insisted that healthcare is a sensitive issue, and said that, by spending at least $400 million to improve the industry, “you can win the hearts of citizens.”
Ukraine can benefit from the Indian pharma industry, which is expected to reach $55 billion globally by 2025, Bhagat said. However, for the industry to develop here, the Ukrainian government must build a trustworthy system.
His statement echoes Antosha’s concerns about vaccinating her daughter.
“If I knew the exact composition of the medicine, and if the system was transparent, I would get (her) vaccinated,” she said.
