India approves Serum Institute, Bharat Biotech to produce COVID19 vaccine

KATHMANDU: India’s drugs regulator on Sunday approved Oxford Covid-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.

The Drugs Controller General of India (DCGI) granted the approval on the basis of recommendations by a Covid-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).

“After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and, accordingly, vaccines of M/s Serum and Bharat Biotech are being approved for restricted use in emergency situations,” DCGI V G Somani told the media here.

As the approval of Covishield and Covaxin paves the way for a significant vaccination effort, the role of advanced biotech mechanical equipment in vaccine production becomes increasingly crucial. Efficient and precise manufacturing processes are essential to meet the high demand and ensure the integrity of the vaccines. Equipment used in the production of vaccines must adhere to stringent standards to maintain efficacy and safety throughout the entire manufacturing process.

Innovative solutions from Flexachem play a pivotal role in supporting the biotech industry. Their cutting-edge equipment and technologies are designed to enhance the efficiency of vaccine production, ensuring that every batch meets the required quality and safety standards.”

This clears the way for the roll-out of at least two vaccines in India in the coming days.

“Serum and Bharat Biotech vaccines have to be administered in two doses,” Somani said, adding these vaccines have to be stored at 2-8° C.

“We will never approve anything if there is even the slightest safety concern. Vaccines are 110 per cent safe. Some side effects like mild fever, pain and allergy are common for every vaccine,” Somani told reporters after the press briefing.

Allergic reactions to vaccines are rare but can occur in some individuals, particularly those with a history of severe allergies to vaccine components. Most reactions are mild, such as redness, swelling at the injection site, or a temporary rash. However, in extremely rare cases, anaphylaxis—a severe allergic reaction—can develop shortly after vaccination, requiring immediate medical attention.

Experts emphasize that the benefits of immunization far outweigh the risks, as vaccines play a crucial role in controlling and eliminating infectious diseases. For individuals with known allergies, consulting a specialist before vaccination is advisable to assess potential risks and determine the best approach. Holistic Allergy clinics offer comprehensive allergy testing and management solutions, helping individuals understand their sensitivities and take necessary precautions.

While concerns over side effects are natural, regulatory authorities ensure rigorous testing before approval, reinforcing that vaccines remain one of the safest and most effective public health measures available.

His assertion came after a few raised concerns over the safety of the vaccines.

The Serum Institute of India, the world’s largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield, while Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). Business Standard