Approval Delay Keeps Dozens of Newly Registered Medicines Off Pakistan’s Market

ISLAMABAD: Around 40 newly registered medicines, including treatments for cancer, diabetes, hemophilia, Parkinson’s disease, heart conditions, and severe infections, have yet to become available in Pakistan because final government approval for their prices has not been granted. Health officials say the issue is not related to increasing the prices of existing medicines, but rather to…

ISLAMABAD: Around 40 newly registered medicines, including treatments for cancer, diabetes, hemophilia, Parkinson’s disease, heart conditions, and severe infections, have yet to become available in Pakistan because final government approval for their prices has not been granted.

Health officials say the issue is not related to increasing the prices of existing medicines, but rather to setting official prices for newly registered pharmaceutical products before they can be legally marketed.

Essential Medicines Await Price Approval

According to officials, several important medicines approved for registration are still awaiting pricing approval from the federal government.

The delay has affected medicines used to treat a range of serious and chronic illnesses, including:

  • Cancer
  • Diabetes
  • Hemophilia
  • Parkinson’s disease
  • Cardiovascular diseases
  • Severe bacterial and other infections

Until official prices are approved, these medicines cannot be legally sold in the country’s pharmaceutical market.

Patients Facing Limited Access

The delay has created difficulties for many patients who require these specialized treatments.

According to the report, some patients have been forced to rely on:

  • Unregistered medicines
  • Personally imported medicines
  • Smuggled pharmaceutical products

Health experts have long warned that obtaining medicines through unofficial channels may expose patients to risks involving product quality, authenticity, and proper storage conditions.

Ministry Clarifies the Issue

The Ministry of National Health Services clarified that the matter does not involve raising the prices of medicines already available in the market.

Instead, officials said the process concerns determining prices for newly registered medicines, which is a legal requirement before pharmaceutical companies can commercially launch them in Pakistan.

The ministry added that price approvals have already been granted for 35 newly registered medicines, while efforts are continuing to secure approval for the remaining 40 products.

DRAP Sends Recommendations

According to the Drug Regulatory Authority of Pakistan (DRAP), recommendations regarding the pricing of the 40 medicines have already been forwarded to the federal government.

DRAP stated that once the government grants final approval, pharmaceutical companies will be able to legally market and distribute the medicines throughout the country.

Officials said the regulatory process is intended to ensure that medicine prices are set in accordance with applicable laws and pricing policies.

Industry Calls for Swift Action

Representatives of Pakistan’s pharmaceutical industry and chemists’ associations have urged the federal government to expedite the approval process.

They argue that delays in pricing approvals are preventing patients from accessing modern treatments that have already completed the registration process.

Industry representatives say timely approval would improve the availability of innovative medicines and help reduce dependence on unofficial imports.

Healthcare stakeholders have emphasized that ensuring prompt access to essential medicines is particularly important for patients suffering from chronic and life-threatening illnesses, where treatment delays can significantly affect health outcomes.

The government has not yet announced a timeline for issuing the remaining pricing approvals, but officials say discussions with the relevant authorities are ongoing.

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