India can be a top pharmaceutical regulator and we want a global authority status, stated Dr S Eswara Reddy, Drugs Controller General of India. The industry and the regulator must be equally visible when it comes to matching global standards. The commitment to quality work cannot be compromised, he added.
India, the pharmacy of the world, is recognised for its affordable and high quality drugs. But there exists dual standards of production. While we export, we ensure that drugs are of global standards. But there needs to be uniform standards, be it global or local markets, he added.
Dr Reddy who was in Bengaluru for a session on ‘The essential journey to Schedule M to PIC/S’ organised by the Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA), stated that the topic was most relevant to the current times. “It is high time India moves from generics to innovative molecules. For this, industry and regulator need to discuss together on the way forward. This is also the beginning of the PICS membership process, which takes five years. Therefore, we need to raise regulatory standards from WHO GMP to PICS.”
It is not mere investment in facilities and having documentation systems in place. There is also a need for a change in working culture. This is where the industry and regulator need to work together for the patients’ benefit, he added.
It is high time India gears up for the PICS regime since three of its neighbours are already in the process of getting there. This includes Pakistan, which has submitted the application. China too has made similar effort and Bangladesh is in the process. The only difference is that these are drug consuming countries, which is easy, but with India, as a producer with large facilities to look into, it is more complex. Therefore, there needs to be capacity and competence for the regulator, who needs to work with the industry, said Dr. Reddy.
In order to be PICS complaint, each inspector needs to be adequately trained, evaluated and certified by the external agency for his competence. For this, we have now assigned LSSDC as the third party associate to develop a training module on par with PICS.
Though decision making in the government is complex, many progressive changes have been made recently. These include scraping of export NOC for port offices after they reported nil violations over a 10-year period.
A decision is underway to hire Pharm D professionals for the enforcement wing since they have expertise in areas like clinical pharmacology and microbiology, which are key skills during inspections. Similarly legal experts are also being considered for the post of drug inspectors.
Concerned about the marketing of counterfeit drugs, the trace and track notification was introduced. Since counterfeiters seldom target low value and unknown brands, it was felt that this regulation was relevant to high value drugs. Top 300 products are being identified. Each strip will be labelled with a unique 14-digit alpha numeric code. Patients can confirm the genuineness of the product by merely sending an SMS or WhatsApp, said Dr. Reddy.
A pharma industry databank is being created. For instance, after the Nipah virus outbreak in Kerala, there was no information about the companies manufacturing Ribavarin, used in its treatment. On a concluding note, Dr. Reddy said that the Indian regulator is looking for suggestions from the industry to facilitate movement from Schedule M to PICS.