Import of innovator-pack-for-CDP-as-per-RX-list-EMA-FDA-WHO

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Imports

Import of Innovator Packs

Now a days the rational medicine use is a right of every patient. As per WHO guidelines Rational use of medicines requires that

“Patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost to them and their community”.

The healthy community is the supreme asset of every culture or country. As we are well aware about the increasing demand of medicine day by day. For example, the available broad-spectrum antibiotics are resistance in more than 80% community. On the other side the people are becoming less immune to diseases. this is not ending here, this the problem in every class of drug, either diabetic or hypertension. The innovators are busy in inventions of new molecules for safe and better treatment. Being a health care provider we are obliged to play our role in public awareness for precautions along with availability of essential medicine for community at any time to not face such huge loss.

Availability of essential medicines is one of the essential building blocks of healthcare system. Essential medicines are those which satisfy the primary healthcare need of the population. These are intended to be available within the context of functioning of health system at all times, in adequate amounts, in the appropriate dosage form with assured quality, and at a price that the individual and community can afford.

In this contrast the local manufacturer plays the supreme role in development of finished pharmaceutical products for the need of local community.

Some leading pharmaceutical manufacturers are focused on the innovations and aimed to fulfil the upcoming community demands of patients. National standard treatment guidelines navigate selection of essential medicine with the expectation to ensure their availability with reference to proper use of medicine within the healthcare system while reducing its cost.

⇒ Import of innovator-pack-for-CDP-as-per-RX-list-EMA-FDA-WHO

With reference to Minutes of 313^th meeting of Registration Board (16-18 Nov, 2021) “Manufacturers shall perform product development studies including pharmaceutical equivalence, comparative dissolution profile (where applicable, preferably using dissolution apparatus with 12 basket assembly) against the innovator / reference drug product as approved by reference regulatory authorities. In case where the innovator / reference drug product is not available in Pakistan, the manufacturer shall get approval from QA&LT Division for import of innovator / reference drug product as per Drugs (Import & Export) Rules, 1976. The Board further advised QA&LT Division, DRAP to permit import of innovator or reference drug product on priority for performing aforementioned studies.

⇒ Transportation

We offer the transportation as per regulatory requirement of product storage. The product will be delivered as per required conditions to save the product from degradation. The cold chain products with data logger for safe and traceable storage conditions to prove the product effectiveness and traits.

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