India blocks further Expansion of the ICH Harmonisation

India blocks the further expansion and therefore the success of the International Conference on Harmonisation (ICH). Together with some patient groups, the country wants to avoid that the World Health Organisation (WHO) continues to be involved in the ICH process.

The ICH is an organisation that has committed to the harmonisation of regulatory standards in the pharmaceutical industry. It was founded in 1990. Members are the drug regulatory agencies in the United States (FDA), in Europe (EMA/EU Commission) and in Japan (MHLW) as well as the industry associations of the three regions (PhRMA, EFPIA, JPMA). The WHO, the European Free Trade Association (EFTA) and Health Canada take part as so-called observers. The International Federation of pharmaceutical manufacturers & associations (IFPMA) is represented in the Steering Committee as a non-voting member.

Since its inception, the ICH has been a success story. While initially only rules were harmonised that were relevant for marketing authorisation/drug approval, a number of GMP relevant documents in the area of quality were developed later as well. These include ICH Q7 (GMP for APIs), ICH Q8 Pharmaceutical Development (Quality by Design), ICH Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and ICH Q11 Development and Manufacture of Drug Substances, which are all relating to the harmonisation of GMP relevant requirements. This completed the extensive range of harmonised quality guidelines, beginning with Q1 Stability and continued with Q2 Analytical Validation, Q3 Impurities, Q4 Pharmacopoeias, Q5 Quality of Bio-technological Products and Q6 Specifications. In addition there are harmonised guidelines in other areas such as safety and efficacy.

That India now prevents the WHO from continuing the successful harmonisation is amazing at first glance. After all, it must be in the interest of all countries to ensure a high drug safety standard and to prevent countries from establishing their own regulations which bring no security gain but increase the cost of medicines.

India is supported in its efforts by various patient groups. The criticism is that in addition to authorities also industry organisations are represented in the ICH Steering Committee (as stated above). Thus, India suspects a misuse of ICH harmonisation. The reasoning behind is that ICH might establish standards that help only the world's leading pharmaceutical companies to protect their drugs against low-cost alternatives from the third world.

Among the group of critics in this initiative against ICH is also the Indian Central Drug Standard Control Organisation (CDSCO). This is interesting because this organisation was criticised with regard to generating the so-called Written Confirmations (GMP Compliance Statement for importing drugs into the EU). While repeatedly severe GMP problems were detected in Indian operations from EU and FDA inspectors, the CDSCO still published Written (GMP) Confirmations on their website (based on ICH Q7 or equivalent) for the same companies that were already evaluated as non-GMP compliant. That same organisation now argues that ICH standards are too high.

According to the patient group Medicus Mundi and People's Health Movement many ICH established standards do not add any value for the quality assurance of medicines and only increase the costs for the production of medicinal products.

It would be more than unfortunate if ICH harmonisation efforts slowed down due to this initiative. The ICH provided an enormous contribution to patient safety. ICH efforts and standards resulted in reduced regulatory costs for medicines. Critics still owe proof that ICH regulations artificially raise standards. It would be fatal if the standards for drug safety would be lowered in some countries beneath those in ICH regions. 

Source: The Times of India article: India thwarts Big Pharma push at WHO assembly