ARTICLE

Moving Past the Patent Cliff: Quality Control and Generic Drug Production

Introduction

Although brand name medicines are widely recognized and trusted by patients, generic medicines can be a more affordable alternative for patients with financial constraints. Misconceptions about product quality may deter certain patients from purchasing generics. However, ever-evolving controls and QC regulations ensure that generic drugs must demonstrate bioequivalence to their name-brand counterparts, sharing essential qualities such as intended use, safety, efficacy, quality, and other performance characteristics.

Generic drugs: The affordable alternative

Although brand name medicines are widely recognized and trusted by patients, generic medicines can be a more affordable alternative for patients with financial constraints. Misconceptions about product quality may deter certain patients from purchasing generics. However, ever-evolving controls and QC regulations ensure that generic drugs must demonstrate bioequivalence to their name-brand counterparts, sharing essential qualities such as intended use, safety, efficacy, quality, and other performance characteristics.

SE-CO-1-4-3-P_quote1.png

These standards must be internationally consistent, as it is often easy to forget the sheer scope of the generic drug industry and the number of impacted patients. India, for example, is one of the world’s largest producers of generic drugs and is currently experiencing a push to increase drug distribution. In a centralized effort to minimize drug expenditures for his citizens, the Indian Prime Minister has called for widespread adoption of generic alternatives, as at least 90% of the domestic market is dominated by brand name drugs.

Generic drugs and quality control

If generics are to be widely implemented as an alternative to expensive brand name drugs, however, patients must be assured of the substitute’s effectiveness. Fortunately, enforcement of rigorous compliance standards by the regulatory authorities exist in regard to drug substance and drug product identity, strength, quality, safety, and efficacy.

Furthermore, apart from bioequivalence, all generic manufacturing, packaging, and testing sites must pass the same quality standards as those of their name-brand counterparts.

SE-CO-1-4-3-P_quote2.png

In the aforementioned case of India, however, doctors must often rely on the reputation of pharmaceutical firms, as there is no international body dictating such standards worldwide. If left unaddressed - this can quickly become an area of concern, as issues that arise in the absence of regulatory safeguards may make generic drugs unsafe to use.

In fact, one of the primary criticisms flagged by foreign regulatory authorities is the poorly managed documentation practices often displayed by Indian generic firms. Not only will such failures preclude reliable and complete datasets regarding specific drug batches, but murky documentation also leads to confusing inconsistencies in the records presented by Indian generics producers.

Improving the status quo

While they may not possess the widespread reputation of brand name options, the low price-point of generic drugs makes them an affordable healthcare alternative. This is certainly the case in India, where, as it currently stands, the improved effectiveness and distribution of generic drugs has been made a national priority. In order for generics to serve as a legitimate safety net, however, significant improvements must be made to their production and regulation.

SE-CO-1-4-3-P_quote3.png

The regulatory solution: GMP compliance

One way of alleviating the regulatory dilemma historically present in the generic drug industry would be to adhere to strict GMP standards. Not only would this eliminate many of the errors listed above, instituting these guidelines would also force Indian generic drug manufacturers to comply with norms specified by various international bodies.

Thankfully, these changes are already on their way, as the Union Health Ministry is currently drafting a guideline meant to align India-specific standards with global regulations for pharmaceutical products. Moreover, India’s drug controller general notably submitted a proposal to the Union Health Ministry which would mandate that Schedule M drug manufacturers are held to the WHO’s GMP standards. By further cementing internationally recognized criteria, such steps are critical in establishing the legitimacy of India-produced generics.

Industry-level solutions: More GMP compliance

The ultimate success of generic drug manufacturers would be to perfectly mimic the effects and performance of name-brand equivalents. To make this a reality, generic drug producers must enact practices that are in line with GMP standards, including but not limited to:

  1. Implementation of robust and reliable data logging systems
  2. Rigorous documentation of all processes to ensure data integrity
  3. Thorough testing of the drug product’s identity, strength, quality, purity, potency, etc.
  4. Thorough testing of manufacturing and packaging processes
  5. Proper maintenance and hygiene in manufacturing plants
  6. Removal of low-quality raw materials
  7. Stocking reliable machinery to mitigate instrument malfunction
  8. Regular maintenance and calibration of all involved instrumentation
SE-CO-1-4-3-P_quote4.png

By implementing strict controls and GMP compliance on the industry level, generics manufacturers can optimize their drug product’s bioequivalence to name-brand alternatives. With generic drug producers holding themselves to the same standards as name brands, consumers can take solace in the knowledge that either option is equally safe and effective.

RESOURCES

Center for Drug Evaluation and Research. (2018, June 1). Generic Drugs: Questions & Answers. Retrieved from https://www.fda.gov/drugs/questions-answers/generic-drugs-questions-answers.

Srinivasan, S. (2017, April 21). Indian government may ask doctors to prescribe medicines under generic names. Is it practical? Retrieved from https://scroll.in/pulse/835207/indian-government-may-ask-doctors-to-prescribe-medicines-under-generic-names-is-it-practical

Kumar, G. (2017, May 10). An analysis of generic medicines in India. Retrieved from https://www.thehansindia.com/posts/index/Hans/2017-05-09/An-analysis-of-generic-medicines-in-India/298834