An arduous endeavour?
In order to prevent the entry of substandard medicines, the European Commission (EC) had issued Directive 2011/62/EU in June 2011. Also called the Falsified Medicines Directive (FMD), the Directive laid down European Union (EU)-wide rules for the import of active pharmaceutical ingredients (APIS).
As per Article 46b(2) of Directive 2001/83/EC, all imported APIs need to be accompanied by a written confirmation from the competent authority of the exporting third country confirming that the plant in which the API was manufactured conforms to the standards of good manufacturing practice (GMP) in the EU.
The Directive provided a ‘short cut’ for selected countries: in accordance with Article 111b of Directive 2001/83/EC the requirement of a written confirmation is waived for ‘third countries’ listed by the EC. The EU has since notified Switzerland, followed by Australia and lastly Japan and the US in June 2013, (just before the Directive became law on July 2, 2013) as third countries. These waivers effectively mean standards of manufacture of APIs in these countries are accepted as equivalent to those of the EU.
Likewise, requests from other countries like Brazil, Israel and Singapore were under examination by the EU for equivalence assessment. Representatives of the Indian pharma industry are of the view that the hassles of issuing written confirmations (certificates) to each company exporting APIs can be avoided, if India’s regulators, the Central Drugs Standards Control Organisation (CDSCO), headed by the Drug Controller General (India) (DCGI) also follows suit and applies to the EU authorities for ‘third country’ status.
Currently, the process is that the CDSCO issues written confirmation based on valid Certificate of Pharmaceutical Product (COPP), as per WHO GMP guidelines, US FDA or EDQM or TGA inspection certificates. In cases where a company has not had prior inspections or certificates, the CDSCO will conduct an inspection.
Repressive regulation?
 “India cannot treat itself as an “island” with its own standards. We must be prepared to join the quality and GMP “continent” with world class standards if we aspire to be the leader in global pharma front.”Dr Gopakumar G Nair CEO, Gopakumar Nair Associates |
The impact of the FMD on API exports to the EU is sure to be felt by the industry. Dr Gopakumar G Nair, Chief Executive Officer, Gopakumar Nair Associates says, “90 per cent of Europe’s API needs are met by Indian pharma companies. Thus the EU is a very valuable customer for Indian APIs.” In fact India and China meet 90 per cent of the global demand for APIs.
As Dr Milind Antani, Head, Pharma and Life Sciences, Nishith Desai concedes, “At present there are administrative issues regarding certificates and confirmations being issued for each company exporting APIs to the EU.“
Putting these stringent regulations into the larger context, Nair says, “What EU is apparently doing is understandably undertaking preventive and prophylactic measures to ensure quality in its supply chain management. The recent trends of USTR/USITC (United States Trade Representative/ the United States International Trade Commission), as well as the EU Parliament restoring the rights to the EU customs for seizure of counterfeit goods including trademark infringing goods, indicates the hard-line which developing countries, more particularly India, is likely to face increasingly in the coming years. However, to meet the EU-GMP guidelines having thousands of API manufacturers with non-uniform standards, both EU and India need each other in the pharma space.”
Nair feels that we are responsible, at least to some extent, for this backlash explaining, “Two factors have dampened the prospects, especially for India. One, the squandering away by the powers that be, the “India Shining” “Incredible India,” “Apna Bharat Mahan”, sloganeering, red tapism and acute lack of “good governance practices” (GGP). Secondly, excessive slogans like “Generic Capital and Pharmacy of the World” has invited strong reactions and counter-measures from the US and Europe.”
Making the case
Burdened with the extra documentation required by the FMD, industry observers point to the obvious benefits of the Indian regulator trying for third country status. Indian pharma companies are of the view that Schedule M of Drugs and Cosmetics Act is equivalent to EU GMP, as it has all the provisions to take care of cGMP compliance. The point is, is the CDSCO/ DCGI ready or equipped to meet this challenge? Are API manufacturers who currently meet only Indian GMP standards ready to equate themselves to EU GMP standards?
Top API manufacturers who export to the US and the EU and whose facilities are inspected and approved as per US FDA and EU GMP standards will welcome the move to equate Indian GMP to EU GMP standards.
 “Indian pharma industry and DCGI must make a joint presentation to EU authorities for equivalent and acceptable assessment of Indian GMP and COPP of API for EU.”B R Sikri Director, ABS Mercantiles |
The current approval process in India is complex yet is in line with the parameters of various global regulatory agencies. Outlining the multi-step process, BR Sikri, Director, ABS Mercantiles says, “Indian API manufacturers get drug licenses from state drug controllers on condition that they follows the provisions of Schedule M of Drugs and Cosmetics Act. After compliance with Schedule M, the manufacturer has to get GMP certification for which there is a provision of joint inspection by state licensing authority and central licensing authority. After getting GMP certification, one has to apply for COPP for each API. Indian manufacturers feel that, WHO GMP and COPP is equivalent to EU GMP and CEP / EDMF of EU.” Thus EU recognition of WHO GMP and COPP will help the Indian pharma industry to grow faster because then the industry can be saved from the hassles of issuing written confirmations (certificates) to each company exporting APIs, says Sikri.
 “There are administrative issues regarding certificates and confirmations being issued for each company exporting APIs to the EU.”Dr Milind Antani Head, Pharma and Life Sciences, Nishith Desai |
Such a move would obviously reduce the timeline and results will be more efficient and accurate. Antani feels, “Indian GMP standards for APIs are at par with global standards and if EU notifies India as third country as regards to standards of manufacture and supervision of APIs equivalent to those of the EU, it will be a major boost for the Indian API industry due to simplified process. This would lead to significant increase in the growth of the API market and will improve relationship with EU API market. And there would also be comfort as regards to the quality of APIs.”
The irony is that Australia, which has far fewer API manufacturers, has taken the pains to ease API, whereas India which is a far larger source of APIs still has not moved on this front.
Working to global standards
If India claims to be the “pharmacy of the world” or “the “generic capital”, it cannot allow itself to be left behind as far as “quality standards” and “cGMP” benchmarks are concerned and Indian authorities need to keep pace with global norms.
Commenting on the issue, Nair says, “India cannot treat itself as an ‘island’ with its own standards. We must be prepared to join the quality and GMP “continent” with world class standards if we aspire to be the leader on global pharma front. For the emerging global scenario, in APIs and formulations, India is perceived as an island with lax regulatory framework. India needs to look at this scenario seriously and take the needed measures while at the same time retaining the national pride and goal of self-reliance.”
Emphasising on whether India too gets a similar recognition from the EU authority, Sikri says, “This will also help Indian manufacturers of finished drug products to source API from India instead of importing from EU approved sources either within India or from abroad. This will give recognition to our country because we are the largest producers of pharma products in the world and this recognition will further strengthen our position.”
Sikri suggests, “Indian pharma industry and DCGI must make a joint presentation to the EU authorities for equivalent and acceptable assessment of Indian GMP and COPP of API for EU. This can be supported by the fact that many Indian manufacturers of API are EU GMP approved and have CEP / EDMF. The number of such manufacturing facilities in India has grown in numbers in the last two decades. This proves that compliance of Indian Schedule M and GMP is equivalent to EU guidelines of cGMP.”
On one side, Indian drug manufacturers are falling short of US FDA GMP standards and are facing import bans. On the other, companies seem to be confident that they are already meeting higher standards and are demanding recognition of this fact. The former is a reality, the latter seems to be wishful thinking … at least for now.
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