On July 13th 2018, the USFDA announced a voluntary recall several medicines containing active pharmaceutical ingredient (API) Valsartan, used to treat blood pressure and heart failure. The recall was due to the API containing an impurity called N-nitrosodimethylamine or NDMA, a possible human carcinogen or cancer causing substance. This API is manufactured by Chinese company Zhejiang Huahai Pharma. The recall has now been extended to over 20 countries.
The Valsartan recall is another example according to experts of poor Chinese manufacturing. Incidents go back to a decade ago with 2007-2008 probably being a low point for China. In 2007 for example, the USFDA found contaminants in pet food imported into the US from China resulting in deaths and sickness in pets across the US. In the same year that toy maker Mattel recalled nearly a million Chinese toys due to lead paint dangers and the USFDA asked consumers to discard toothpaste made in China as it contained diethylene glycol, a poisonous chemical.
In 2008, in what was probably one of the most serious incidents yet Chinese exports of blood thinning drug Heparin were adulterated resulting in the death of 81 people and 785 serious injuries in the US. In 2016, US company Lumbar Liquidators decided not to sell laminate flooring sourced from China on concerns of it containing cancer causing substances. And in 2018, besides the Valsartan recall, the USFDA have informed drug makers in August 2018 not to use porcine thyroid API manufactured by Sichuan Friendly Pharma. This is over quality concerns as the API contains inconsistent levels of levothyroxine and liothyronine. The API manufacturer is asked to recall all batches of the API since 2015.
Instances of poor manufacturing standards are not just limited to the US. In 2008, six children died and 300,000 were sickened due to an incident of milk being laced with melamine, a plastic type substance. In 2012, Hunan Ava Dairy recalled baby formula after cancer causing agents were found in test samples with other incidents of milk containing high levels of mercury. The list goes but one of the latest examples is of 250,000 defective vaccines being administered to children in China, manufactured by one of the country’s largest vaccine manufacturers –Changesheng Biotechnology.
India, realizes this Chinese quality issue too. In January 2018, the drug controller of India – DCGI banned APIS from six Chinese companies. This alert was issued after inspection of the units by Indian regulators and a lack of quality compliance by the units. And with regards to the Valsartan API recall no locally available drug that uses Valsartan procures their API from ZH Pharma, so our products are safe. The DCGI has conducted the necessary checks, contacted the required ports and internal offices to keep a check on the issue in India. The exposure in India is in fact limited to one registered import agent and four Indian companies including the likes of Torrent Pharma that used the API only for exports. Torrent Pharma has recalled 16 lots of the drug manufactured by them for the US market.
While one cannot paint every company and in this case an entire country with one brush, the trend of severe issues emerging from noncompliance in China cannot be missed. Having said that China is actively trying to improve manufacturing standards. In June 2017 the country became a member of the International Council of Harmonization of Technical Requirements or ICH which requires adopting technical standards and guidelines. The latest measure has been a hard crackdown on cos not following regulatory and environmental guidelines. This has resulted in a suspension of a large number of API manufacturers. The crackdown has impacted Indian companies that import cheap key starting material or KSM (material to make the API) or the API itself from China. India sources 75-80 percent of API requirements from China. This supply shortage from China has caused a cost escalation of anywhere between 30-50 percent on an average. These 30-50 percent price rises are expected to sustain for at least the next one to one and half years and will eventually have to be passed on by finished dose manufacturers or take a margin hit.Whether it is an argument on quality or over dependence on supply, the larger picture is that India is uncomfortably dependent on China on KSM and API supplies. And while India does have capacity to manufacture these key ingredients indigenously experts believe we lack the scale and cost competitiveness to bridge the gap effectively.