IMPLEMENTATION OF THE EU FALSIFIED MEDICINES … · IMPLEMENTATION OF THE EU FALSIFIED MEDICINES DIRECTIVE, 2011/62/EU ... European Commission’s directive is of particular ... Microsoft

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IMPLEMENTATION OF THE EU FALSIFIED MEDICINES DIRECTIVE, 2011/62/EU

from the perspective of Indian manufacturers and Indian authorities

IPA/EDQM/WHO 2012, Mumbai

S.M.MUDDAMicro Labs Limited, Bangalore

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Contents:

Background

Overview of the Directive

Role of Indian Manufacturers and Indian Authorities

Comments from International Associations

FALSIFIED MEDICINES DIRECTIVE, 2011/62/EU

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Background:An alarming increase in falsified medicinal products was seen over a period past few years although exact extent is not confirmed. Both through illegal means and through legal supply chain As the risk to public health and safety was seen increasing, The European Commission's Directorate for public health and risk assessment issued Directive 2011/62/EU from 8th June, 2011 amending Directive 2001/83/EC for preventing entry into the legal supply chain of falsified medicinal products.


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Background:The Directive’s main aim is to protect patients from thethreat of falsified medicines.

It was adopted by the European Council in May 2011

Published in Official Journal 1st July 2011

Each member state must transpose Directive2011/62/EU before 2 January 2013 outlining laws, regulations and administrative provisions necessary to comply with the Directive.


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Background:

The new legislation comes into force on 2nd January, 2013 to those carrying out manufacturing, importing, placing on the market, and the wholesale distribution of medicinal products in the European Union.

Control on Import of Active Substances from 3rd

countries from 1st July 2013

Registration forms to the competent authority must be submitted by 2nd March 2013.


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Falsified Medicinal Product – Directive Definition: Any medicinal product with a false representation of:

Its identity, including its packaging and labelling, its name or its composition as regard any of the ingredients including excipients and the strength of those ingredients.

Its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorization holder, or

Its history, including the records and documents relating to the distribution channels used.

The definition does not include unintentional quality defects and is without prejudice to infringements of intellectual property rights


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The aim of the Directive is to control the falsified medicines through various measures at different stages:

Addition of safety features for Prescription Medicines and for Non-prescription products at risk of falsification.

Supply Chain and Good Distribution Practices for wholesale distribution of medicinal products in the Union extending Regulation to brokers. Also includes import from 3rd country for re-export of medicinal products to 3rd country (products ‘introduced’ in EU)


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The aim of the Directive is to control the falsified medicines through various measures at different stages:

Active Substances - Control on quality of Active substances and excipients. Quality to be certified by the National Competent Authority (NCA) of the 3rd

country. Finished Product Manufacturers responsible for ensuring EU GMP compliance of API used by him.

Internet Sales


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Controls on Active Substances:

Finished product manufacturer must ensure that APIs it uses have been manufactured in line with EU GMP & distributed in line with EU GDP by conducting audits. (Art. 46 (f))

Applicant for MA must confirm in writing that manufacturer of finished product has verified compliance with EU GMP of API manufacturer through audits (Art. 8 (3))


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Same applies for those excipients considered to pose a risk after applying a risk assessment. (Art. 56 (f)).

Competent Authorities of Member States must ensure that manufacturer, importers, distributors of APIs on their territory comply with EU GMP & EU GDP for APIs (Art. 46b).


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Manufacturers, importers & distributors of APIs established in the Union must register themselves with the Competent Authority 60 days prior to commencement of their activity.

Those already in operation have to submit their registration by 2nd March 2013 (Art. 52a)


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APIs can be imported only if manufactured in accordance with EU GMP and the competent authority of the exporting country submits a written confirmation that exporting country has standards, inspections and enforcement similar to that of the EU (unless on approved list of countries issued by Commission) and that in case of any non-compliance it immediately notifies the Union (art. 46b & 111b)


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Inclusion in the list of Approved Countries:

The Commission shall assess at the request of a 3rd country, their Regulatory frame work applicable to APIs exported to the EU to ascertain that the control and enforcement activities ensure a level of protection of public health equivalent to that of the Union.


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India Stand on FMDs:The idea of the European Commission seems very difficult to understand and appears impracticable.

Each shipment of API or drug raw materials from India should be accompanied with a written confirmation, vouching that the quality of the exports conforms to EU standards.

The implementation of the EU directive with respect to this issue not only requires knowledge of the regional GMP requirements but also practical experience, besides having the necessary capacities and resources.


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India Stand on FMDs:

The country’s drug exports to the EU were worth $1.93 billion (around Rs 10,769 crore) in 2010-11.

If India fails to get an EU equivalence certificate by 2 July 2013, when the rule is set to go into effect, 30% of this could be affected

The EU initiative while citing the reasons of safety and public health appears to be protectionist and may act as an economic barrier for India


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The term “falsified medicinal product” in the European Commission’s directive is of particular concern in India.

“While the directive is pertaining to API, the word ‘falsified’ could be used broadly to apply to generic drugs made in India,”

“If an Indian company makes a generic version of a drug patented by a multinational pharma company, it could come under this directive and be treated as a ‘falsified’ or spurious drug and be confiscated.”


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India Stand on FMDs:The Government is planning to conduct feasibility check of training Indian Drug Inspectors on EU standards.

Meetings between the representatives from Commerce and Health Ministry on matter has been initiated.

The DoP also do not want to delay this any further. But the only concern is the use of the term ‘Falsified’.

A recent press release states that the government appears to be convinced that the Indian drug companies have a case and are looking at various alternatives, including approaching WTO...


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Certain Inconsistencies:

QP Certification of API continues. Appears duplication of control.

Control is only on API sold as pure material. May not apply to modified APIs and not to the Drug Product.


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Comments from International Associations:

From Parenteral Drug Association (PDA)

Certification of APIs from 3rd Country: What will be involved? Who and when will a list of “approved 3rd

countries” be issued ?What is involved in “self-certification of

equivalent GMP” by a 3rd country ?How will exceptions be handled and for how long ?


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Comments from International Associations:From European Industrial Pharmacists Group (EIPG)

The regulatory GMP Compliance inspection is essential but is often not undertaken due to limited resources.The EDQM is very effective, since they inspect the API manufacturing process, and provide a 3-year certificate of suitability. However, this is limited to drug substances in the European Pharmacopoeia.Problems with APIs not present in any pharmacopoeia and supplied from third countries, since regulatory authorities do not have resources to adequately monitor GMP compliance.


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Comments from International Associations:From European Industrial Pharmacists Group (EIPG)

Regulatory agencies should ensure that at time of submission of marketing authorization, all details of CTD module 3S (Drug Substance) are supplied as well as means by which GMP will be monitored.

Rapid alert system should link with WHO and FDA to obtain early warning of problems

Lack of resources in EMA and other agencies is a problem.


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Conclusion:Effective implementation of the current measures should be the first option to explore rather than going for additional controls Ultimately, this will lead to an increase in the costs of medicines without corresponding benefit of control on quality Interim provisions shall be put in place: Exception to EU GMP- compliant facilities, QP Certified APIs and facilities should be considered Mutual Cooperation plan with third countries for improving the regulatory framework


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Conclusion:

Can impact adversely the availability of quality API from the EU GM certified suppliers, impacting the patient need

Whether the directive 2011/62 EC increases the safety of patients with respect to falsified medicines in conjunction with the described import restrictions remains questionable.


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THANK YOU FOR YOUR ATTENTION

S.M. MUDDAExecutive Director – Technical & Operations

MICRO LABS LIMITEDNO.27, RACE COURSE ROAD

BANGALORE – 560 001Mobile:+919972029070

[email protected]

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IMPLEMENTATION OF THE EU FALSIFIED MEDICINES … · IMPLEMENTATION OF THE EU FALSIFIED MEDICINES DIRECTIVE, 2011/62/EU ... European Commission’s directive is of particular ... Microsoft