In this release, we consider the rising costs Indian pharmaceutical manufacturers face from global market demands.
International, national, and state regulatory actions have provided both lessons and actions for Indian pharmaceutical enterprises. Indian enterprises not being seen as sufficiently strong in Good Manufacturing Processes (GMP/CGMP) practices suffer from diverse news and likely reputational damage.
The scandals for adulterated cough medicine for children in Gambia and Uzbekistan began in July 2022 and led to the identified deaths of 89 children. The World Health Organization is also investigating deaths of up to 300 in Gambia, Indonesia, Uzbekistan, and four other countries.
The USA FDA is investigating relevant GMP compliance in global locations that may export to the USA. Of particular interest to the FDA and other regulators is whether or not suppliers to the plants for the contaminated lots of cough syrups were in common.
Product samples from six different manufacturers in India and Indonesia were tested and found to be contaminated. The manufacturers have denied producing contaminated product or declined to comment while probes are ongoing.
More recently, the US FDA has linked a non-sterile eye drop made in India to an outbreak of a drug-resistant bacteria. In at least 55 patients in 12 states of the USA, the medically adverse events are tied to at least 55 patients with infections, blindness, and one fatality. The manufacturer initiated a voluntary recall for products distributed to the USA.
Indian State and Federal Government regulators investigating the eyedrop events said they are traced to a drug not sold in India produced by a contract manufacturer. The supply chain vendors of raw materials have not been publicly identified. The USA FDA announced that the manufacturer had violated USA GMP guidelines required of any plant producing for the USA market. For example, CGMP guidelines for active pharmaceutical substances call for continued retention and testing of samples for three years after the last lot of manufactured substance has been distributed.
The Health Minister announced that testing of 89,000 drug samples in 2021-2022 by states/territories had more than 2500 substandard results (2.81%), and about 380 were declared spurious or adulterated. This is a surprisingly high level of failures. A catchphrase of the manufacturing industry is that profit cannot be “tested in.” In the case of contract or irregular manufacturing lines, the Indian Federal and State bureaucracy will also certainly act to protect the interests of a greater India.
The next post will discuss implications and reactions to the most recent issues.
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