Drug quality concerns take centre stage at pharma export council’s global meet

Regarding concerns about the drugs manufactured by some companies, DCGI Raghuvanshi said such aberrations will always be a minor part of the whole piece.

Speaking at the 9th annual International Pharma Exhibition (iPHEX), Indian authorities highlighted that the government has prioritised quality control of drugs to quell the concerns about medicines exported from India.

Rajeev Raghuvanshi, the Drug Controller General of India (DCGI), also said that the regulator is working to rationalise drug regulations in the country.

“We are hiring global consultants to look into the opportunities of rationalisation,” he added.

Raghuvanshi said the non-uniform implementation of the Drugs and Cosmetics Act in the states was a challenge, and added that there was ‘scope of improvement’ in this.

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iPHEX, organised by Pharmexcil and the Ministry of Commerce and Industry to showcase India’s capabilities to delegates from other countries, is one of the biggest pharma industry events in the country.

Uday Bhaskar, Director General of Pharmexcil, said that medium, small, and micro enterprises (MSME) should especially focus on quality compliance and patient safety in their manufacturing process.

“The interests of consumers and their safety is of prime importance. If a product doesn’t take patient safety into consideration, it is irrelevant,” he added.

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Bhaskar, who has suspended the registration of at least three companies responsible for manufacturing contaminated drugs, said such companies damage India’s reputation.

Asked about the quality issue dominating the discourse at the export council’s meeting, Bhaskar said the quality issue was a key point of discussion as it was denting India's image as a pharmacy hub.

“If a bad thing is happening, it impacts confidence. If you don’t discuss, how do you address the problem,” he added.

Avoid shortcuts for gains

Raghuvanshi said that Indian drug manufacturers have to come out of their short-term mindset aimed at quick gains and adopt a  long-term strategy.

“We have the potential to triple the size of the pharma sector. But unless we realise that quality is at the core, we will not be able to realise the potential,” he added.

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Identifying the varied size of the manufacturers in the pharma industry as one of the biggest challenges, Raghuvanshi said it becomes difficult for the regulator to design a regulation which is optimal for different categories (MSMEs as well as big pharma).

“The MSMEs have to move up the value chain. A lot of harmonisation with global pharmacopeia will happen in the coming days,” he added.

Regarding concerns about the drugs manufactured by some companies, Raghuvanshi said such aberrations will always be a minor part of the whole piece.

“Regulators are not for policing, their role is to facilitate. As stakeholders, we have  to ensure that these aberrations do not  impact the value we have created as a country,” he added.