The World Health Organisation (WHO) and the United States Pharmacopoeia Convention (USP) will extend technical assistance to the Indian drug regulatory authorities to streamline the standards of biologics for better acceptance in the overseas markets.
The WHO, USP and the Central Drugs Standard Control Organisation (CDSCO), along with the National Institute of Biologicals held a high-level interactive meeting here recently and explored the possibility of setting up research centre in India to support standards and promote access to good quality biologics including biosimilar and interchangeable medicines.
USP, which is already having a collaboration with the Indian Pharmacopeia Commission, will be focusing on biologics as part of the tie-up and will hold regular scientific meeting with Indian experts, USP chief executive officer Dr Roger L Williams told Pharmabiz.
Apart from Dr Williams, WHO representative, Dr Ivana Knezevic, DCGI Dr G N Singh, National Institute of Biologics director Dr Surinder Singh and CRI director Dr Sunil Gupta were among the host of top officials who took part in the interaction.
Appreciating the success of biotech industry of India, Dr Williams said country has greater potential to explore in the developed markets, but needs to bolster the standard aspects. “Indian biologics are doing well and going well with regard, but need to further improve the standards to win the overseas markets. Indian system should move rapidly. There are marvelous opportunities,” he said.
Referring to the debate on naming the copycat biologics (which were described as similar biologics in the recent guidelines), he suggested that India should better follow the rest of the world and adopt the word 'biosimilars'.
The USP chief said the US is way ahead in the case of standards for biologics, but compared to the Europe, it still lagged behind by many years. “India is going fast and can catch up with the rest of the world,” he added.
On persisting issue of counterfeit drugs from India, he blamed it partly on the perception. “With internet sales, there is a problem of fake drugs. It is a reality. But it is perceived as a bigger problem. There is a suspicion about the quality. Truth alone does not matter, it is also perception,” he said referring to the exaggerated figures about fake drugs from India in the western media.