Generic Drugs Current Affairs
World Health Organization (WHO) has invited pharmaceutical companies around the world to submit proposals to manufacture affordable versions of newer medicines for treatment of drug resistant tuberculosis (DR-TB). It has now requested drug makers to submit Expression of Interest (EoI) for Bedaquiline and Delaminid, two new-generation drugs, recommended for DR-TB. The aim of this proposal is to replicate success of addressing HIV epidemic. Under WHO norms, drugs submitted upon such requests and complying with its standards will be included in list for procurement by UN and other organisations.
India has nearly 1.3 lakh DR-TB patients, most in the world. Currently Health Ministry gets only 10,000 doses of Bedaquiline and 400 doses of Delaminid. These medicines are obtained as donations from Janssen (US) and Otsuka Pharmaceuticals (Japan), their respective manufacturers.
EoI considered by WHO for two drugs will be key compounds to address challenges of DR-TB. It will encourage generic competition to start finding ways to make these medicines available in countries where they are not yet registered. It will also allow generics manufacturers interested in producing these two drugs and currently facing technical challenges. The pre-qualification will ensure greater numbers of manufacturers are supplying quality medicines, which, in turn, means a more competitive market and more affordable prices.
The World Health Organisation (WHO) has dropped the term ‘counterfeit’ and retained ‘falsified’ to describe medicines of inferior quality.
This decision was taken by a WHO’s technical working group on draft working definitions of substandard/spurious /falsely-labelled/falsified/counterfeit (SSFFC) medical products.
It settles longstanding India, EU medicine dispute and battle about labelling of drugs. It is considered as a significant victory for the global access to medicines campaign.
What is the issue?
- The above mentioned terms were used interchangeably to confiscate Indian made cheap generic drugs exported to other countries by showing that they were in violation of Intellectual Property Rights (IPR).
- It was also alleged that big pharmaceutical companies were using term ‘counterfeit’ to describe generic medicines and disrupting trade of generic medicines especially from India.
- Even the European Union Free Trade Agreement (EU FTA) was derailed after affordable, safe-to-use generic drugs made in India were confiscated as ‘illegal’ and ‘counterfeit.’
- Between 2008 and 2009, nearly 20 shipments of generic drugs were detained while in transit from India to several developing countries via Europe.
What were the concerns?
- Under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) — the definition of counterfeit was clearly targeted at one particular area.
- It clearly mentioned that it is wilful infringement of trademark on a commercial scale.
- However in reality, campaigns and legislation against counterfeit drugs often have nothing to do with concerns about drug quality.
- The major European and US pharmaceutical companies used these rules for vested interest by limiting competition from generic drugs.
- They were using increased enforcement of IP laws as a tool to clamp down on the legitimate trade in high-quality generic medicines between developing countries
Significance of WHO decision
- The adopted definition will use falsified and drops the word counterfeit. The term falsified is much more in line with public health concerns regarding medicines.
- It makes false claims about what they contain or where they are from, that represent a genuine problem.
- It clarifies that the term ‘counterfeit’ will now be used by member States with respect to protection of IPR.
- Settles a long-standing battle about labelling of drugs as for far too long, genuine generic medicines have been labelled as counterfeit.
- Removes confusion on the much needed attention from the substandard medicines — which is a bigger public health problem for developing countries.
WHO is a specialized agency of the United Nations that is concerned with international public health. It was established on 7 April 1948. It is headquartered in Geneva, Switzerland.