Food and Drug BlogPharmaceutical Industry : New Requirement for Generics and Multisource Drug Products

August 6, 2014

Nowadays, multisource and generic drug products are booming in the pharmaceutical market due to the rising public demand of effective but cheaper medicines.

Filipinos try to get the best out of every peso they grab from their pockets, that’s why they prefer to buy things that are close to the original ones and costs less rather than those of the patented ones.

In a recent article at People’s Pharmacy, a patient named Karen Bartlett from New Hampshire took a Non-steroidal Anti-inflammatory (NSAID) pain drug prescribed by her doctor in December 2004 to ease the discomfort inflicted to her by her painful shoulder. But instead of being cured from an ordinary shoulder pain, she developed a life-threatening reaction called the Toxic Epidermal Necrolysis (a rare, life-threatening skin condition that is usually caused by a drug reaction) and Stevens-Johnson syndrome (milder form of Toxic Epidermal Necrolysis).

The generic drug given to her was identified as Sulindac, an NSAID that was once exclusively sold by Merck after being approved by the FDA in 1978 under the brand name of Clinoril, but later on became available as a generic in the early 1990’s.

The generic formulation that Bartlett took was from the Mutual Pharmaceutical Co. which was a division of Sun Pharmaceutical Industries, Ltd., of India.

Disastrous adverse drug reactions like these occur often from the generic drugs that are produced after the patent of the original drug product expires. This is because a lot of drug manufacturers and distributors now have the freedom to create their own formulation based from the original drug product through the approval of the FDA.

Their products may be approved, but these generic and multisource drugs may or may not be the same with the original one because the manufacturers, traders and distributors are selling them for a lower price which leads us to the possibility that they aren’t putting the same dose, etc. on the generic drugs they’ll be selling in the market.

This is one of the reasons why the Supreme Court ratified the FDA to enforce a mandatory requirement of BA/BE studies to lessen, if not eliminate, generic products that may cause severe adverse reactions due to careless drug manufacturers last March 5, 2014.

Through the declaration of the Supreme Court that the Bureau Circular Nos. 1 and 8 series of 2007 are valid issuances of the FDA, the State, through the FDA, can further more ensure that the generic drugs and medicines available in the market are safe and effective for use by requiring the submission of satisfactory BA/BE results for products identified under List B (Prime).

With this very important step taken by the Philippine government for the safety of all Filipino consumers, everyone is advised to buy only from FDA-licensed drug outlets and pharmacies, and to demand official receipts for future tracking of transactions.

The FDA Philippines released an official advisory about the BA/BE studies requirements and mandated it’s all FDA field inspectors to keep an eye in monitoring unregistered, counterfeited or smuggled medicines in the country, particularly anti-TB and other antimicrobial drugs.

Last June 2013 the FDA Phils released a new list of products requiring to submit BA/BE reports. The FDA Circular 2013-014 states the list of pharmaceutical drug that requires BA/BE report as part of the requirements for application of Marketing Authorization. The circular took effect last July 1, 2013 and full implementation of the circular was January 1, 2014.

Triple I Consulting is willing to guide you through the product registration process, and in preparing the legal requirements to ensure the safety and efficacy of your products. Our Regulatory Affairs Department is able to provide proper assistance in the preparation of documents to minimize certain incomplete requirements for regulatory approvals and to avoid rejection of registration or licensing.

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