Generic drug is the medicine that is created identical to the already existing drug in the market. The ingredients of these medicines are similar to the branded medicine and can conclude that the generic medicines are substitute of branded medicine. As it is similar to the branded medicine their effects and clinical benefits are similar. Moreover, the generic medicines are cost effective; therefore, it can reach to the people of all classes. Now, here the most important and obvious question arises that despite the same ingredients are used why these medicines are cheaper than branded?  The generic medicines are cheaper because various initial steps is eliminated while manufacturing generic medicines such as clinical trial, animal testing etc. and that results in deduction of cost.

Why there is a need to manufacture generic medicine in India?

By approving various generic medicines available by different companies, Food and Drug Administration (FDA) create competition in the market and that eventually leads in easy availability of drugs in the market at lower cost. Drug Competition and Action Plan (DCAP) is introduced by FDA to ensure healthy generic market in the country so that the patients can have the access to these medicines at affordable price. The plan mainly works on the three functions:

  • Improving the competence of the generic drug development, review and approval processes.
  • Updating regulatory requirements for generic drugs while maintaining evidence based medicine practice.
  • Work on the loopholes that branded medicine creates for delaying generic drug approval.

Why the generic license is not approved just after the launch of brand name medicine?

A lot of expenditure is incurred while manufacturing a new drug on research and clinical trial, so it is essential to recover the cost of manufacturing from that drug. And by getting patent right the company protect the drug from being copied. Therefore the generic license is not approved just after the manufacturing of branded drug.

What information needed to be submitted for approval of generic medicine?

The manufacturer needs to submit the manufacturing process to the FDA for ensuring that they are manufacturing high quality product identical to the branded medicine. Additionally, they have to submit the details regarding the active and inactive ingredients present in the generic medicine.

In addition to this, the manufacturer has to conduct human study and the submission of same is required. The human study includes voluntarily taking of both generic and branded medicine so that the safety and quality can be ensured.

After submission of the above information the professionals and scientists check the data collected for analysing the quality and efficiency of generic drug. If the company needs to change any particular thing in the drug the change needs to be notified to the authorities.

What is the criterion for granting FDA approval?

  1. Before granting approval to any generic medicine it is ensure that the active ingredient used in the medicine is same as of the brand name medicine and will work effectively after consumption. Also, the inactive ingredient used in the medicine is safe for consumption and will leave no after effect. The ingredients used in the medicine are acceptable and good for health.
  2. The generic medicine is of same strength than as of brand name medicine.
  3. The route of administration of generic medicine must be similar to that of brand name medicine such as if brand name medicine is for oral use then the generic medicine should be of nature i.e. oral.
  4. The generic medicine should indicate the same usage method as indicated on the brand name medicine.
  5. The shelf life of both the medicine should be same. In lay man language the expiry of generic medicine should be same as of brand name medicine.
  6. The generic medicine should be manufactured under the strict standard adhering with the batch requirement for identity, strength, purity and quality.

What is the estimated time period of FDA approval?

Generally, it takes six month or less than six months for the approval but it can vary in the case of complex medicine as the complexity makes it difficult to analyse. Aside from that the time period also vary according to the use of that drug as if the drug is of the kind that has a long term effect on public health needs more time for approval.

What are the measures to minimise FDA approval time?

In order to minimise the approval time the companies has to take the following measures:

  • Study well on FDA guidelines before creating the product or before submitting the application to the authorities.
  • Get in touch with the department by conducting meeting in which they can ask question related to drug development process.
  • The company should ensure that they submit the complete information required for the approval indication that the drug is safe, effective and substitutable to the brand name drug.

To cap it all, the concept of generic medicine largely deals with the health of public; therefore, it is essential to keep check on the approval process. The company should take effective measure to manufacture the drug in cost effective measure, so that it can be reachable to public at large. The pharmacists are directed to advice patients about the substitute available in the market at reasonable price with the similar quality and effectiveness.

-Surbhi Singla

Associate at Aggarwals & Associates, Mohali.