Hyderabad: The Office of the Drug Controller General of India (DCGI) has again asked for comments on replacing the gelatine capsules made of materials derived from animals such as cows and buffaloes, with cellulose based ‘vegetarian’ capsules. This follows strong opposition from the drug manufacturing industry.
On September 5, the Central government issued a notification extending the date for comments by another 15 days, as reservations were expressed regarding technical difficulties in making vegetarian capsules.
Industry bodies are against Hydroxypropyl-methyl cellulose, stating that gelatine capsules are safer and cheaper. Making drugs ‘vegetarian’ will increase the production costs at a time when the Centre is demanding a decrease in the costs of medicines, the pharma industry pointed out.
The expert committee of the Office of the Drug Controller General of India, said in the recent notice: “The Directorate General of Health Services has earlier issued public notice on June 2, 2017 seeking suggestions and comments from manufactures and marketers of HPMC capsules as well as NGOs working on the subject.
The directorate has received various comments from different stakeholders and the same was placed before the expert committee to look into technical issues pertaining to replacement of gelatine capsules with cellulose based capsules for encapsulation of drugs. The committee is now asking for representations from those who haven’t made any representations, within 15 days.”
The pharma industry believes costs can increase by four times if cellulose based capsules are made compulsory.
Drug manufacturers have questioned the Centre’s claim that vegetarian capsules are safer than gelatine ones. They say that gelatine - based capsules are time tested and also have technical advantage over cellulose capsules.
