European Commission Enterprise and Industry Directorate-General may seek enforcement of its amendment made to Part II of the Good Manufacturing Practices (GMP) Guide on July 31, 2010 on Indian drug companies. The set of stringent guidelines focus not only on production of high quality and pure active substances but include wide gamut of operations. These include receipt of materials, responsibilities for traders, distributors, brokers, agents, re-packers and re-labellers. It has also mandated the need for a system in place to document manufacture of APIs used in clinical trials.

The rules governing medicinal products in the European Union, changes to Part 2 of the EU GMP guide will bring it in line with the ICH Q9 guideline on Quality Risk Management.

The amendments correspond to similar changes made to Part I, Chapter 1 of the Guide and published in February 2008. A new section on Quality Risk Management is introduced as section 2.19. The remaining sections of chapter 2 are re-numbered. A minor change is made to section 2.21. As a result, it will no longer be identical to the ICH Q7 guideline on Active Pharmaceutical Ingredients (APIs), which is a harmonized guideline for the US, Europe and Japan. It includes more requirements than the original ICH Q7 text which was transferred to the EU regulation by amending the EU GMP Guide under Annex 18. The Annex 18 is called Part 2 of the EU GMP Guide while Part 1 includes the GMP requirements for medicinal products.

According to a communiqué from the European Compliance Academy, the revisions to Annex 2 were necessary to make clear that all annexes (1–20) are applicable to both medicinal product manufacturers and API manufacturers.

According to Kaushik Desai, chairman, Industrial Pharmacy Division, IPA and CEO, Global Pharmatech, of late, Quality Risk Assessment is given prime importance by every regulatory agency. The EU GMP guidelines for active substances are now on par with those prevalent in developed countries brining in uniformity of quality requirements. Going by the inflexible and strict surveillance the move will definitely discourage dubious operators and create better prospects for genuine players. Going by India’s presence in EU, the country will need to bring its regulations on par with global guidelines.

The GMP guideline were first published in November 2000 as Annex 18 to the GMP Guide. It is an EU’s agreement to ICH Q7A which has been used by manufacturers and GMP inspectorates on a voluntary basis. The guidelines apply to the manufacture of active substances for medicinal products for both human and veterinary use.

The amended guidelines will make it stringent for companies marketing in the region. Only quality players will succeed in the market, stated Anjan K Roy, president, Karnataka Drugs Pharmaceutical Manufacturers Association (KDPMA) and managing director, RL Fine Chem.

On July 13, 2010, Raichur-based Shilpa Medicare Ltd, was approved by the French Health Products Safety Agency (AFSSAPS) and issued GMP compliance certification for production of gemcitabine hydrochloride. This will help the oncology bulk drug major to market in EU. “The new EU GMP guidelines to be enforced by July-end will allow companies to submit dossiers only if they have adhered fully to the EU norms so far. This move is welcome as only quality conscious companies will set to prevail keeping fly-by-night operators at bay,” said Vishnukanth Bhutada, managing director Shilpa Medicare.