Indian Pharmacopoeia Commission (IPC) of the Drugs Controller General of India (DCGI) has started a complete revision of 13 common but antiquated drugs in order to re-evaluate them on the aspects of safety, efficacy, and adherence to contemporary pharmacopoeial requirements. Drug companies have been asked to provide their license approval letters granted by the Central Drugs Standard Control Organization (CDSCO) or state authorities for the manufacture before 28 February 2025.

Important Highlights:
Re-evaluation of Old Drugs for New Standards

• The Indian Pharmacopoeia Commission (IPC) is testing drugs licensed 30-40 years ago to check if they are relevant today, safe, and effective.

• The evaluation is a part of an effort to revise the Indian Pharmacopoeia (IP) according to current standards of quality and safety.

Drugs that Are Being Re-evaluated
The 13 listed drugs are:

• Clindamycin Lotion – Applied for skin allergy.

• Nitrofurantoin Oral Suspension – Treated for bladder infection.

• Dexamethasone – It treats inflammation of the skin, joints, lungs, and other organs.

Implications for the Pharmaceutical Industry

• Firms are required to furnish CDSCO or state license approvals for these drugs, adhering to revised safety and efficacy norms.

• Indian Pharmacopeia (IP) norms are enforceable through law, and any lapse could lead to regulatory action.

India's Push for Pharmaceutical Self-Reliance

• Government funding for drugs and medical devices has risen by 29%, from ₹4,090 crore in FY24-25 to ₹5,269 crore in the current Union Budget.

• India's pharmaceutical exports in FY23-24 were $26.5 billion, while imports were $7.1 billion, solidifying India's position as the third-largest medicine manufacturer in the world by volume.

• India continues to be the biggest supplier of drugs to UN agencies and sends more than 50% of its pharmaceutical products to highly regulated markets such as the US, EU, and Japan.

Statements from Officials:
Regulatory Official:
"These medicines have been on the market for decades. The review is to make sure that they still adhere to the current safety and efficacy standards. Manufacturers are required to follow IPC standards, which are the legal standard under the Drugs and Cosmetics Act."The Indian government's decision to re-evaluate older drugs is in line with international regulatory practices, prioritizing patient safety and adherence to changing scientific standards. The drug firms have to file the necessary approvals by 28 February, following which new guidelines can be released for production, testing, and quality control.