Context: Government has set a deadline for mandatory implementation of the Good Manufacturing Practices (GMP) following the incidents of deaths allegedly linked to “contaminated” India-manufactured drugs.
Global Issues
- More than 60 children in Gambia died after kidney complications, allegedly caused by cough syrups made by the Haryana-based Maiden Pharmaceuticals.
- A cold remedy, manufactured by Marion Biotech in Noida, was blamed for the deaths of 19 children in Uzbekistan.
- A batch of cough medicines produced by an Indore-based firm was blamed for at least 12 fatalities in Cameroon.
Data on Regulation of Drug Mfg. Companies
- According to health ministry data, less than 20% pharma units in the country have WHO certification.
- In India only 2,000 of the 10,500 manufacturing units have been found to be compliant with the global WHO- Good Manufacturing Practices (GMP) standards.
Provisions for Regulations of Drug Mfg. Companies
- Central Drugs Standard Control Organization (CDSCO), Ministry of Health & Family Welfare, provides general information about drug regulatory requirements in India.
- The Drugs & Cosmetics Act, 1940 regulates the import, manufacture, distribution and sale of drugs in India.
- Schedule M of the Drugs and Cosmetics Act, 1940 specifies requirements for factory premises and materials, plant and equipment and minimum recommended areas for basic installation for certain categories of drugs.
Issues with the Current Regulations
- Outsourcing of Production: Studies have shown that the major companies outsource their production to MSME outfits, where quality is often compromised for cost.
- Regulatory Issue
- Poorly staffed and under-resourced state regulatory bodies find it hard to deal with the ways of these firms whose supply chains regularly involve fly-by-night operators.
- Drug inspectors are often tasked with administrative work related to the cancellation and renewal and inspection of licenses. Scrutiny of drugs for safety and efficacy suffers as a result.
- Lack of laboratories: The country has 29 state government-run and two Central drug testing laboratories, which are not enough for a country size of India.
- Supply-Chain Issues:
- Incoming raw materials are not being tested before using it to make the drugs.
- The final product quality is not being reviewed properly.
- There is an absence of regular quality-failure investigation.
- There are infrastructural deficiencies to prevent cross-contamination of the product.
- Faulty design of manufacturing and testing areas amplifies the already present problems.
- Lack of qualified professionals which results in sub-standard drug formulation.
- There is poor documentation of the test, result and their review.
- The WHO has flagged concerns about the quality of Indian generics and has found toxic content in seven Indian-made cough syrups.
- There is no database on inspections and violations that alerts regulatory authorities, healthcare institutions and doctors.
- Lack of information in the public domain about the procedures followed during the investigations that create the trust deficit.
Govt Steps to Address the Lacunae
- The government asked drug manufacturing companies for mandatory implementation of the Good Manufacturing Practices (GMP) bringing them on par with World Health Organisation (WHO) standards.
- Larger companies with a turnover of over Rs 250 crore have been asked to implement the changes within six months.
- Medium and small-scale enterprises with turnover of less than Rs 250 crore have been asked to do so within a year.
- Companies who do not comply with the direction will face suspension of license and/ or penalty.
WHO Good Manufacturing Practices
Good manufacturing practice (GMP) is that part of a quality management system to ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.
GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, it may broadly be categorized into two groups: Cross-contamination/mix-upsFalse labelling
Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy.
GMP Guidelines
The revised GMP guidelines focus on quality control measures, proper documentation, and IT backing to maintain quality of medicines produced.
- GMP Computerised System
- It will be designed to automatically record all the steps followed and checks done and ensure that all the processes are followed and prevent unauthorised access and changes to the data.
- In case sensitive data is entered manually to the system, there will be additional checks to validate the accuracy of the data.
- Backups would also be created to ensure there is no loss of data.
- Stability Studies: it says companies must conduct stability studies as per the climate conditions, keep the drugs in a stability chamber, set the proper temperature and humidity, and carry out an accelerated stability test as well.
- Quality Control: it introduces pharmaceutical quality system, quality risk management, product quality review, and validation of equipment.
- Revised schedule M: It lists the requirements for additional types of products, including biological products, agents with radioactive ingredients, or plant-derived products.
Benefits of Effective Regulation for India
- Instituting the same quality across the industry will give confidence to regulators from other countries
- This is a very welcome step by the government as it will ensure that all the manufacturing units in the country are at par with global standards, reducing the need for repeated inspections by different regulators.
- It will make India a quality pharmaceutical hub of the world. In addition, it will ensure that our citizens also receive export-quality medicines.
