On August 6, the quality assurance (QA) division of the CDSCO had released guidelines on the procedures to be followed by its inspectors during GMP inspections. The guidelines may not be too path breaking but this notice marks a significant step towards the adoption of uniform procedures during regulatory inspections across the country. Whereas most notices have been instructions to industry, the August 6 notice from Dr GN Singh, Drug Controller General (India) is a clear message to his fellow regulators, that they will have to perform to these standards.
The notice has seven points where the DCG(I) has laid down specific guidelines. For instance, GMP inspections as well as that for Certificate of Pharmaceutical Product (COPP) need to focus mainly on Schedule M requirements to establish shelf life, validity studies and recalls besides the WHO GMP requirements. It also mentions that inspections should be conducted for two to five days, depending on the size of the manufacturing facility.
The DCG(I) is also clear that inspection reports have to be finalised ‘without delay’ when there are critical observations having a direct impact on the quality, safety and efficacy of products and which call for initiation of immediate regulatory action (i.e. drug recalls). The state drug control authorities have been asked to qualify inspectors for inspection based on experience and training and more importantly, to ensure that each inspector carries out a minimum of five GMP inspection in a year ‘to sustain performance’.
In effect, the DCG(I) is laying out annual inspection targets per inspector, as well as parameters to be followed to standardise inspection across states. Will these guidelines be enough to hold state inspectors accountable? Will these be enough to raise confidence in the standards of GMP inspections in India?
There has always been the view that inspections conducted by local regulators are less stringent than global inspectors. This is cited as the reason why pharma manufacturing plants in India have being slapped with warning letters from the US FDA. However, industry observers point out that these notices from the DCG(I)’s office seem merely “procedural and a formality”. Until the DCG(I) is given more freedom to operate and actually crack down on errant inspectors, these will not be enforcable.
There is hope that the new Government will elevate the DCG(I)’s position so that his bark will have more bite, but until then, nothing much will change. Just as there needs to be a change in attitude, and a cultural shift towards quality in the industry, we need to see the same change among regulators.
Unfortunately, we are reactive rather than proactive. Regulations for clinical trials started changing only once a public interest litigation (PIL) was filed in January 2012 by Swasthya Adhikar Manch blowing the lid off many unethical practices.
Two years later, the matter is still being heard by the Supreme Court. Notwithstanding the industry’s lament that many trials, both global and local, are at a stand still and have also moved to other countries, the Government has gone ahead and bought clinical trials services within the ambit of service tax in the recent budget. Which means that the additional 12.36 per cent tax will be added to the cost of conducting trials and therefore to the cost of drug development. Industry associations like ACRO and ABLE are also worried that the Government’s plan to use IT-enabled systems for clinical trials will discourage participation as patient privacy will be compromised.
As we go to press, we await yet another hearing on the drug pricing policy on August 29. The authorities need to take a more rational and consultative stance on all these issues.
Viveka Roychowdhury
Editor
