In a stark and direct contrast to China’s efforts to improve product quality that we reported on earlier, the Times of India yesterday reported on a new study conducted by The Associated Chambers of Commerce and Industry of India (ASSOCHAM). Noting the shortage of adequate inspectors (1,500 inspectors for more than 10,000 manufacturing facilities), the study cited a variety of other factors that if not addressed ASSOCHAM felt would conspire to undermine India’s $31 billion pharmaceutical industry. Also identified as prime contributing factors were:
- Lower awareness of acceptable quality standards by inappropriately trained staff,
- Lack of a central, uniform regulatory system, and
- Insufficient funding for small and medium manufacturers to implement a robust quality program.
The result, according to ASSOCHAM secretary general D. S. Rawat is that “we [India] need to get our own house in order by way of continuous skilling of regulators at national and state levels in sync with the best global practices. However much we may wish otherwise, pharma sector is and will always remain one of the most regulated sectors all across the world for the sake of public health.”
While they say awareness is the first step to enlightenment, it is clear from the study that India has a long and arduous journey ahead if it wishes to continue manufacturing and selling quality pharmaceuticals on the world stage.
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