Drugs from India: Focus on quality outcomes to change perception.
Quality and safety are the major aspects of any medicine for every citizen of any country, as it is affecting human life. Every manufacturer takes efforts to ensure that the systems, processes and regulations of manufacturing country and of those where they are exporting.
The USFDA report of 2019 titled, ‘The State of Pharmaceutical Quality for CDER regulated drugs legally marketed in USA’, rates average compliance score of drugs from India as 6.8 in a scale of 1 to 10. In fact, amongst all the regions, India ranked lowest in USFDA’s scale of compliance. The highest compliance number, 7.7 was attributed to EU manufacturers followed by the US (7.6) and China (7.3). Even Rest of the World (ROW) scored higher (7.0) than India.
Like IT sector, Indian pharmaceutical sector needs to now focus on change in perception on drugs from India. While most are still struggling to increase their sales in the US, there is momentum and is being aided by their new drug launches. For instance, in the first quarter of this financial year (FY21), Dr Reddy’s, whose US sales contribute the most at 39% (sales in India were at 14%) of total sales, saw a year-on-year growth of 6% in revenues from the
region along with new product launches in the US. Others too like Lupin and Cipla have also launched new products.
Bottle of facts:- According to health economic times
1. India amongst top five pharmaceutical industry
Globally, Indian pharma has outperformed to improve public health outcomes, it accounts for 60 percent of global vaccine production. India’s exports of generic drugs have also been growing at a very impressive rate of 24% per year for the last four years. Majority of exports is done to highly-regulated western markets. Even the cost of HIV/AIDS treatment has reduced to $400 per year from $12,000.
2. Indian Generics a boon to US Healthcare system
In last years, US healthcare system has saved almost $2 trillion due to usage of drugs from India.
This clearly indicates the efficiency of the Indian pharma sector in terms of quality and pricing.
3. Decreased OAI Inspection
According to USFDA data, when the issue was pointed out during inspections, the Indian organizations made healthful measures, and witnessed 4% inspection which is classified as Official Action Indicated (OAI) in 2018 as compared to 15% in 2017 indicating improvement in inspection outcomes. That means improvement in knowledge, quality culture, strength and capabilities of the Indian pharma have not been enormously improved.
4. Continuous training of drug inspectors to inspect total quality
The All India Drug Control Officers Confederation had organized workshops to train drug inspectors across the country. The Central Drugs Standard Control Organization is trying to strengthen Indian regulators through training so that they can match international standards. Around 150 drug inspectors residing in western India were trained at Gandhinagar, so that they improvise inspection skills. Similarly, such workshops were held at different regions across the country.
5. Developed guidelines for data reliability, investigations, process validation and good documentation practices
The Indian Pharmaceutical Alliance (IPA), consists of a group of leading Indian pharmaceutical companies such as Cipla, Lupin and Cadila Healthcare, had established a quality forum in May 2015 with the aim of total quality and not only compliance, with the help from McKinsey.
