Indian Drug Regulation Needs a VITAMIN

The Indian pharmaceutical industry ranks third internationally in volume. India is a chief exporter of pharmaceuticals with more than 200 nations served by Indian pharma exports. India supplies more than 50% of Africa’s requirement for generics, around 40% of generic demand in the USA, and around 25% of all medicine in the UK. Although India is proud of being the ‘pharmacy of the world,’ it would be right to say that the drugs regulatory bodies and laws must take the spate of oft-warnings more seriously. In the recent past, India has been beaten by a few mega pharma worries. The world mostly depends on the Indian pharmaceutical industry. However, growing worries over quality and the absence of drug regulations policy lead to the query of whether India is dwindling in its role.

- Shivanand Pandit

# In February 2023, an Indian pharmaceutical company based in Chennai, Global Pharma Healthcare, deferred a line of eye-drop manufacture being distributed in the USA market after the nation’s health authorities warned that it could be adulterated with drug-resistant germs that have been related to statements of eternal vision damage and one death from bloodstream contamination.

# In December 2022, the Central Drugs Standard Control Organisation (CDSCO) instigated an investigation concerning the death of eighteen children in Uzbekistan supposedly connected to a cough syrup produced by an Indian firm Marion Biotech based in Uttar Pradesh.

# In October 2022, the World Health Organization (WHO) issued a medical produce warning. Four products from India-based Maiden Pharmaceuticals based in New Delhi were adulterated with intolerable volumes of diethylene glycol and ethylene glycol, both poisonous to human beings. 

Drug regulation and supervision, also known as Pharmacovigilance is imperative in ensuring the safety of medicines and safeguarding patients from harm. As per the law, the Central Drugs Standard Control Organisation (CDSCO) is the apex supervisory association. The CDSCO delegates the Drug Controller General of India (DCGI), the authority to act as the governing head. The DGCI must perform under the guidance of the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC).