The death of children got attention. The possible cause was cough syrup with Indian pharmaceutical origins. Indian government authorities immediately investigated exporters of products to the affected countries. Deaths of more than 300 children were reported across Cameroon, Gambia, Indonesia, Marshall Islands and Micronesia, and Uzbekistan. Over the last year the scandal has widened as the USA Food and Drug Administration (FDA) has joined efforts with the World Health Organization.
A Dynamic India must act effectively and in a rapid transparent manner to reduce the damage to Indian-industry reputation and global expectations of quality. The damage may be even more wide spread if the Indian legal process can’t rapidly compel manufacturers, and their suppliers, to act in a responsible manner. Indian regulators will see actions by importing countries and major international regulators acting if they cannot. The Indian legal process will be ignored by international regulators if appropriate protections for global consumers can’t be implemented – Indian products will simply be banned and their reputation degraded.
The USA FDA has the power to inspect and require corrective actions in manufacturing plants whose products will be exported to the USA. Less well known is the FDA’s power to compel manufacturing process changes for record keeping and testing. Global health agencies have been looking for the source of problems in the months since the contaminated childrens’ medications were found by lab testing.
The contaminated medication saw diethylene glycol and ethylene glycol (banned in the USA) in doses. The chemicals glycerin (glycerol) and propylene glycol are used in some medications to dissolve drugs like acetaminophen (often paracetamol outside the USA) otherwise not soluble in water. Manufacturers using less-than “pharmaceutical-grade” chemicals, to lower costs, risk contaminants being toxic when taken as medication.
The FDA acted in at least 28 cases to send warning letters and other notices to manufacturers across the globe. A key change required by the FDA was to require a change in the supply chain materials testing. Previously a manufacturer might ‘sample’ an ingredient for purity or standards compliance. The FDA changed the guideline practice so to require manufacturers to test individual lots of ingredients and materials. The tests were required to determine if ethylene glycol or diethylene glycol were present. Certificates or supplier tests were not considered sufficient for compliance. Per lot tracking is a requirement of cGMP (Current Good Manufacturing Practices) and requires traceability of supply chain elements all the way thru to the administered medications. Obviously, costs are higher to build a solid business process, perform the testing, and then be able to trace the specific lot of ingredients all the way to a consumable dose of medication.
The FDA’s actions affected prescription, and over the counter, medications from US-based companies and exporters from Canada, Egypt, India, South Korea, and Switzerland. Products from those manufacturers included cough and cold medicines, earwax removers, nasal spray, hand soap, shampoo, toothpastes, sunscreen, diarrhea medicines, mouthwash, and pink eye treatments.
The number of FDA’s actions in the last 12 months were more than the last 5 years by some analysis (Reuters). The FDA acted after a long history of contamination incidents dating back to the 1930s.
Indian regulatory and legal processes are different from regulators like the USA FDA or European Medicines Agency (EU). A number of manufacturers and suppliers under investigation have had repeated incidents and continued to contest regulatory actions and recommendations. These investigations are ongoing even as Make In India initiatives continue with pharmaceuticals identified as a key export category.
Effective compliance with global manufacturing standards, like cGMP, will be required for Indian export products across sectors like pharmaceuticals, electronics, chemicals, and fuels. Besides the products themselves the compliance data for traceability of the supply chain, manufacturing process, and chain of custody will be as important to exporting the products. A Dynamic India must build an effective capability and competency to perform to global standards in each of these product categories in order to be successful.
For more analysis and our deeper looks see http://www.ekalore.com/india-business
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