Tag Archives: Regulatory Aspects

Challenges facing active pharmaceutical ingredient production

Active pharmaceutical ingredient (APIs) production face also of problems especially china and India.

The following are challenges facing API companies.

Pharmacie, drugs, Generic drug

Regulatory Problems

In this is inspection. When API industries are not thoroughly inspected defective products will not be detected however, this may cause life- threatening products or even ineffective commodities in the hand of the public.

The regulatory system must ensure that API production companies operates under legality however, lack of inspection will lead to defective products distributed to the public.

API production companies have failed to follow the rules and regulation passed by the regulatory board. Many industries are ignoring the public health and are motivated by greed through practicing fraud or illegality intentionally.

API production companies have faced challenges of controlling repacking and relabeling of products by other people hence duplication of API products.

Limited Approval of New Chemical Entities

In the past few years the rate of new chemical entities has declined rapidly. This is according to the research done by IMS.

The reason behind this decline due to the increase of high safety standards and scrutiny by FDA (food and drug administration authority).

Products Delays and Non-Approvals

It takes 10-12 years for a new medicine to be approved from launch to distribution

Increased generic competition

In this case big API production companies spends millions of dollars from discovery to product launch. This process takes years hence bringing delay to approval.

Technology Transfer

Technology transfer is associated with risk that require management. Transfer of technology from one culture to another is complex and more complicated due to the cultural differences of the involved sites of the organization. In this aspect technical skills are also required for the facilitation of the operation. Training and development of employee’s skills must be established in order to catch up with the new technology discovered.

Regulatory Aspects

Due to the short timeline given by the regulatory, it’s difficult to cope with the challenges of the manufacturing sit directed by the regulatory system.