Where is India’s pharma market headed? Regulatory infrastructure must be put in place to ensure global quality

  • Indian drugs are failing at the WHO quality standards and those required by the western drug regulating authorities

  • While there are 12,000 manufacturing units in India, only 25 percent of them comply with GMP standards

  • Adding to the woes is the lack of awareness among the patients between the efficacy of branded generics and generics

The pace at which the “pharmacy of the world” is growing, there’s no denying that India is utilising its full potential. An evaluation of Rs 1.1 lakh crore (FY 2017) and a global market share of 20 percent speaks volumes about our place in the global market. The Indian pharmaceutical market (IPM) is expected to grow at 9-12 percent compound annual growth rate (CAGR) between 2016-21.

Owing to the increase in government investment in the health care sector with the launch of Ayushman Bharat, the domestic market is expected to witness further expansion. However, that is only one side of the story. The other side—Indian drugs are failing at the World Health Organisation (WHO) quality standards and those required by the western drug regulating authorities like the Food and Drug Administration (FDA).

It was not too long ago that the USFDA had found deficiencies relating to medicine quality in India. The issue still persists. In fact, the ‘Special 301 Report’ by the United States Trade Representatives (USTR) slammed India and China as leading sources of counterfeit medicines distributed globally with 20 percent of all pharmaceutical products sold in the Indian market is estimated to be counterfeit.

 Where is India’s pharma market headed? Regulatory infrastructure must be put in place to ensure global quality

Representational image. Reuters.

This does not fit well into India’s status of “world’s pharmacy”. This makes it rather imperative to put in place a regulatory infrastructure to ensure that global quality and safety demands are adhered to—both, at the domestic and export fronts.

Where does India stand on the barometer of quality drug manufacturing?

If you look at the quality of drugs manufactured for the domestic market, many manufacturing units are reportedly not compliant with the WHO’s good manufacturing practices (GMP) or good laboratory practices. While there are 12,000 manufacturing units in India, only 25 percent of them comply with GMP standards. There are few nationally accredited laboratories in India.

The demand for 62,000 pharmaceutical products is to have adequate and industry-specific drug testing laboratories in place. However, at present, there are only 47 test facilities listed under the National GLP programme of which, six Central laboratories sample around 8,000 drugs per annum, resulting in insufficient output to satiate the demands. One significant yet unintended spill-over of low output, low-quality pharmaceuticals is the rise to another beast—drug-resistant diseases. When a strain of tuberculosis, for instance, is exposed to substandard levels of a medicine that aren't strong enough to contain it, the strain evolves into resisting further antibiotic action. Therefore, with the existing multiplying problems facing the pharmaceutical industry, it is certain that drug resistance would further plague India’s health profile.

The case of Jan Aushadhi

Another push by the government–Jan Aushadhi Multi-Purpose Stalls (MPS) under the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) scheme catapulted the growth of “generics-only” India. A move such as this, promising to bring health care within the reach of the common man, has been marred by its own set of complications. Five medicines have been recalled from Jan Aushadhi stores in the last 20 days alone due to quality lapses. There were six other recalls between January and March, taking the total to 11 in just the first four months of 2018 while there were 11 recalls in all of 2017.

Such frequent drug recalls are unusual in India, where a single recall can land a company in serious trouble, including legal action, an export ban, and financial losses. Drugs are typically recalled if the product is defective, contaminated, contains a foreign object, fails to meet specifications, or is misbranded. There are many other issues of quality, partiality in procurement modalities and irrational combinations that affect the timely availability/supply of right drugs

By opening Jan Aushadhi centres without supply and quality assurances, and without substantially increasing the health budget, any mass movement to achieve universal health coverage is bound to fail. Can we afford to be careless on the quality aspect of drugs just to introduce cheaper variants of a drug? It’s a question that’s looming large in the Indian pharmaceutical market today.

Leaving a patient confused is not a sign of a healthy pharma ecosystem

Adding to the woes is the lack of awareness among the patients between the efficacy of branded generics and generics. The latest blow by the government is making it mandatory for the doctors to prescribe generic salt, giving authority to the chemist nexus to grow to further incompetence and lowering quality standards. All efforts meant to achieve universal health coverage somehow missed the basic but crucial factor i.e., quality. The gamut of "generics only India" is finding an anchor in the subcontinent and it is disturbing to the state of millions who expect quality over just price.

The systemic sidelining of the brands entering the domestic space by pushing hard for cheaper alternatives cannot be seen in a socio-welfare spirit. Irrespective of the export or domestic distribution, a drug must be manufactured under the same safety protocols enlisted under the WHO. It’s not fair to suddenly stop a patient from consuming a drug that has fostered trust based on results. In my opinion, I would suggest we are nowhere near relying solely on generics, since they do not meet safety standards of their exported versions.

(The writer is project officer–capacity building and M&E, UNDP)

Updated Date: Jul 16, 2019 19:21:08 IST