As of today, it looks difficult for both India and China to join the PIC/S or the ICH. And that’s bad news for the global pharmaceutical industry, which is hugely dependent on both these nations for drugs and APIs.
Two years ago, India’s pharma regulator, the Drug Controller General of India (DCGI) G N Singh had said: “If I have to follow US standards in inspecting facilities supplying to the Indian market, we will have to shut almost all of those”. This statement highlighted the difference in quality standards used around the world.
Singh shared his concerns with the major drug regulators across the world. Even as India and China become increasingly important to the global pharma industry, regulatory inspections at drug manufacturing facilities in both India and China report back rising incidents of non-compliance in the areas of quality and data integrity.
In a recently held conference in Washington DC, Paul Hargreaves, chair of Pharmaceutical Inspection Co-operation Scheme (PIC/S) said neither of the countries has any plans to join PIC/S or the International Council on Harmonization (ICH).
While the PIC/S is a non-binding, informal co-operative arrangement between Regulatory Authorities for the development, implementation and maintenance of harmonized Good Manufacturing Practices (GMPs) standards, the ICH is a project that brings together the regulatory authorities of Europe, Japan and the US as well as experts in the three regions.
The purpose of these bodies is to help establish globally
acceptable quality standards and have the industry avoid multiple regulatory
checks on drugs and manufacturing facilities.
Challenges at the ground level
China plays a critical role in the global marketplace for pharmaceuticals. India, a major exporter of finished drug products, is also relying on China for majority of its bulk drug imports.
China is also the largest producer and user of antibiotics in the world. Therefore, the world is also keeping a close watch on China to combat the global menace of antibiotic resistance.
Over the years, China has expressed interest in joining PIC/S, Hargreaves said. The PIC/S has met he China Food and Drug Administration (CFDA). However, China is a complex market. “They have different inspectorates in different territories and regions,” he added.
There are also political disagreements over issues such as whether Chinese Taipei and Hong Kong fall under China or not.
According to Hargreaves, China would need agreement across the whole country in order to join PIC/S. Even though conversations with China are going on, Hargreaves said it will have to be either the whole of China or none at all.
Geneva-based PIC/S has also been insisting that India join the league. Last year, there was news that India is looking at persuading thousands of drug makers to upgrade their manufacturing facilities to help the country meet PIC/S standards.
However, Hargreaves said the situation in India is “very difficult”. He noted that India’s pharmaceutical industry is “very much against joining PIC/S” as it’s too expensive. India would have to raise standards significantly to meet PIC/S requirements.
The PIC/S now has 49 countries as members. By joining the PIC/S, Indian drug companies get faster access to these markets. Countries like Armenia, Bulgaria, China, Nigeria, Saudi Arabia, Uganda, Vietnam and Zimbabwe have expressed interest to join PIC/S.
The cost of quality
The Indian government has been meeting trade bodies to decide on a timeframe for compliance. However, according to Hargeaves, if India were to adopt GMP standards for drug manufacturing, patients in India would not be able to afford the medicines.
Non-compliance has an even severe fallout. First, instances of regulatory non-compliance challenge India and China’s stature as drug exporters. Second, with the pharma world increasingly dependent on China and India, regulatory action can lead to acute shortages of drugs.
In the US, more than 80 percent of drug ingredients are produced overseas, and mostly in China and India. Recently, the FDA allowed a Zhejiang Hisun plant in China – which had been banned from exporting to the US due to regulatory issues – to export 15 ingredients for use in finished drugs in the US in order to avoid possible shortages of drugs. This included nine key cancer medicine components.
Vietnam – which is joining the PIC/S – has also raised an issue with the Indian government over the quality of drugs from India.
Earlier this month, there was news that the ministry of
commerce and industries is planning to set up a committee, along with the Central Drugs Standard Control Organization
(CDSCO), to inspect Indian pharmaceutical companies which have been banned from
The absence of India and China from PIC/S and ICH is a cause of concern, in view of the rising instances of FDA (and other regulators’) warnings, Form 483s, banned products and import alerts against manufacturers from these two countries.
While there may be a cost attached to improving quality, the cost of neglecting quality maybe even higher in the long run. And, there are no short cuts to adhering to GMPs.