Medication abortions are one of the preferred methods for ending pregnancy around the world in contrast to surgical, according to the World Health Organization. Over the past 30 years, more than 60 countries have liberalised their abortion laws and India is among them. All women, including those not married, could get an abortion for up to 24 weeks in India.
Debates around abortion rights have become more prominent nowadays but the medications and how safe they are, have taken a back seat.
A report by Bloomberg news agency has claimed that an Indian drug manufacturer, which supplies abortion pills to America’s DKT International, has been failing in quality tests since 2018.
Delhi-based Synokem Pharmaceuticals sells abortions and postpartum hemorrhage-related products to DKT at an affordable price. However, more than 30 samples of drugs made by Synokem including generic abortion pills, an antibiotic, and anti-seizure medicines — have failed quality tests conducted by Indian regulators and public health researchers since 2018, Bloomberg reported citing government records.
Abortion pills are typically made by mixing ingredients in batches that can produce 100,000 to 1 million pills at a time. As per the report, the shoddy samples of Synokem comprises impurities and lacked the right amount of active ingredients. Despite failing to meet international standards, Synokem has sold drugs to pharmacies and other distributors. However, it must be noted that Synokem abortion pills haven’t been linked to any deaths or serious injuries.
In 2021, the Concept Foundation, a Geneva-based nonprofit that supports access to quality-assured sexual and reproductive health medicines, analysed Synokem samples. The Foundation found that eight samples contained levels of impurities in excess of international standards. The Concept Foundation purchased those samples from India, the Democratic Republic of Congo, Nigeria, Cambodia, and Uganda.
‘SYNOKEM PRODUCTS IN THE US’
DKT International, which has become one of the world’s largest sellers of abortion pills through its splashy marketing campaign, buys products from Synokem even though they haven’t received approval from the US Food and Drug Administration.
The Washington DC-based nonprofit has some of the major donors, including the Bill and Melinda Gates Foundation which has contributed more than $90 million to DKT over the past decade.
The abortion kits, which contain misoprostol and mifepristone, are being purchased through underground online pharmacies that have no affiliation with DKT.
Synokem’s cheaper drugs, which cost up to 40% less than more closely vetted alternatives, have helped DKT sell more pills in the US.
Chris Purdy, DKT’s chief executive officer defended its relationship with Synokem to Bloomberg agency. “DKT has not received any complaints from pharmacies, hospitals, or other customers about the manufacturer’s products,” Purdy said. Founded in 1983 by JM Arora, Synokem’s relationship with DKT began about 20 years ago when the nonprofit was looking to expand from condoms into prescription medicines.
‘SIDE EFFECTS OF SUBSTANDARD ABORTION PILLS’
The number of patients harmed by substandard medicine is difficult to track and frequently goes undetected, particularly in places where healthcare resources are limited. Women who have relied on the medicine for an abortion may also be reluctant to come forward.
Several international aid organizations, including the United Nations Population Fund, routinely send inspectors to assess manufacturers’ practices. They also buy medicine whenever possible from manufacturers vetted by the World Health Organization or the strictest regulatory authorities such as the US FDA. Synokem’s facilities, like many of India’s roughly 10,000 drug factories, do not participate in this kind of vetting, which can be costly for manufacturers.
‘WHAT DOES INDIAN REGULATOR SAY’
Under Indian law, the harshest penalty for producing substandard drugs is criminal prosecution, though it has rarely been used. A bill pending in parliament would allow manufacturers of some poor-quality drugs, such as those without enough active ingredients, to avoid jail time by paying a fine.
The Uttarakhand regulator this year suspended Synokem’s license to manufacture the product for three months after finding a lack of active ingredients in samples of misoprostol.
In an investigation by Bloomberg, it was revealed that at least 23 samples of Synokem’s drugs have failed quality tests since 2018. One of the tests, involving a misoprostol sample collected at a hospital pharmacy in 2019, had so little active ingredient that a government-run hospital network warned all its members to stop using any medication from the entire batch, official records show.
Synokem’s quality problems haven’t stopped it from attracting international interest. Earlier this year it received an investment from TA Associates. Synokem’s customers also include Abacus Pharma, a company owned by the Carlyle Group that serves East Africa.
Synokem makes drugs for Indian market and subcontracts for big generic pharmaceutical companies such as Sun Pharmaceutical Industries Ltd., Cipla Ltd., and Macleods Pharmaceuticals Ltd., according to its website. It also exports to more than a dozen countries, records show.
Notably, the union health ministry this year found multiple deficiencies among drugmakers following wide-ranging inspections across the industry, including a lack of raw materials testing.
The authorities stepped up scrutiny of drugmakers in recent months after some cough syrups made in the country were linked to the deaths of at least 95 children overseas.
The ministry said it has upgraded ‘Good Manufacturing Practices’ under the Drugs and Cosmetics Rules to check the deficiencies found during the inspections.
Large drugmakers have been given six months and small manufacturers 12 months to transition to the upgraded manufacturing requirements.
