The drug market in India not only manufactures drugs to be used in the country but also for export to other countries of the world (Basak, 2018). There are different international policies and laws as well as country-specific laws that pharma companies need to follow for the export of drugs. There is a good number of evidence that international policies drive pharmaceutical allergy drug market of India.
Major importers of the Indian pharmaceutical drugs
The major importer of the Indian pharmaceutical drugs and the regulatory policies governing the import of drugs into the country is given in the following table.
International Policy followed
|1.||US||Food and Drug Administration for ANDA & GDUFA|
|2.||UK||EU good manufacturing practices (GMP)|
|3.||South Africa||South African National Drug Policy|
|4.||Russia||Drug Procurement Law (44-FZ)|
|5.||Nigeria||National Agency for Food & Drug Administration and Control|
|6.||Brazil||ANVISA (National Health Surveillance Agency)|
|7.||Germany||German Narcotic Drugs Act|
However, WHO plays a big role in organizing regional and global meetings of regulatory agencies to improve the exchange of information and to establish common principles of drug regulation (WHO, 2013). It has made progress in harmonizing the rules and regulations that guide the export and import of pharmaceutical drugs around the world. The main focus lies in the exchange of information and informal contacts for better standards in drug innovations and developments. These policies allow safe pharmaceutical drugs to be imported into respective member countries. However, the guidelines make it tough for Indian pharmaceutical companies to manage and maintain the guidelines of all importing countries.
International policies drive export of Indian pharmaceutical drugs
The export of the Indian pharmaceutical products has risen 7.55% from 11.66 billion dollars in the year 2014 to 12.54 billion dollars in the year 2015 (Livemint, 2016). However, with the increase in the regulatory concerns and pricing pressure in the global market India’s pharmaceutical exports grew merely 3% to USD 17.3 billion in 2017-18 (The Economic Times, 2018). The major factors behind this decrease in export percentage by Indian pharmaceutical companies are the increase in the strictness of rules and regulation for the import in the U.S by the US Food and Drug Administration, regulatory hurdles in many countries and currency fluctuation around the world.
All these factors contribute to slow growth in the overseas shipment of pharmaceutical drugs to other countries in the world. These regulatory agencies play an important role in deciding the export percentage rate of Indian pharmaceutical drugs because over 55% of India’s exports go to highly regulated markets (The Economic Times, 2018). In addition, different countries have different guidelines, which makes it impossible for small scale industries to target a larger international market. Moreover, the costs of applications and manufacturing increase with the increasing need for different quality assurance reports of drugs. Thus, international policies definitely drive the export of Indian pharmaceutical drugs and the growth of the allergy drug market.
Challenges and motivations of international policies on the Indian drug market
The stringent regulatory authority of various countries acts as the major challenge for the allergy drug development in India. The pharmaceutical companies require continuous due diligence and observation of their products for quality. This makes the companies indulge in pharmacovigilance approach and proactive quality assurance approach. Thus, the company’s adaptability will increase the quality perception of the Indian drug market internationally. This acts as a motivation to pharmaceutical allergy drug market. However, the Indian local regulatory bodies must join PIC (Pharmaceutical Inspection Convention) to raise the standards of the local regulators.
This will eventually increase the quality standards of the drugs produced by the Indian pharmaceutical companies and lower the costs of quality expenditure made for exports to different countries. It will also increase the export of the allergy drugs and enable expanding the allergy drug market of India. However, it has been seen that the export percentage of Indian drugs are increasing every year in spite availability of strict international regulatory policies. Higher growth in outbound shipments helps create employment opportunities, earn foreign exchange and boost economic activities of India. Therefore, international policies can act as a motivation for the allergy drug market in India.
- Basak, S. (2018). Pharmaceutical Market and Regulatory Contents for Export of Pharmaceutical Products to Latin American Countries. IOSR Journal Of Pharmacy, 8(4), 60–72.
- Livemint. (2016). India continues to lead China in pharma exports – Livemint. Retrieved on 21st September 2018 from https://www.livemint.com/Politics/g0vsJg1hoVWJQ7qyBf7WmI/India-continues-to-lead-China-in-pharma-exports.html.
- The Economic Times. (2018). Pharma exports up 3 pc to $17.3 billion in 2017-18 – The Economic Times.
- USFDA. (2015). What is FDA. Retrieved on 21st September 2018 from https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/pharma-exports-up-3-pc-to-17-3-billion-in-2017-18/articleshow/65338198.cms
- WHO. (2013). WHO Expert Committee on Specifications for Pharmaceutical Preparations. Retrieved on 21st September 2018 from https://www.who.int/medicines/services/expertcommittees/pharmprep/en/