Writing on the wall for Indian drug manufacturers

In what can be a clear warning to the erring pharmaceutical companies in the country, a nation-wide raid was conducted by the national drug regulator---the Drugs Controller General of India (DCGI)—against manufacture of spurious and substandard medicines. This led to cancellation of licenses of at least18 pharmaceutical companies across 20 the country. The national drug regulator made surprise inspections on 70 units Himachal Pradesh and around 45 in Uttarakhand, the two leading pharma manufacturing hubs that accounts for the majority in the domestic market. Action against over 20 companies in Madhya Pradesh has also been initiated.

The cancellation of licenses of 18 companies for manufacturing spurious or substandard drugs is the outcome of the risk-based inspections planned by the Central Drugs Standard Control Organization (CDSCO) last December. Risk-based inspection criterion is based on the number of sub-standard samples of the respective manufacturer found in the market in the past three years. Risk-based inspections are based on current good manufacturing practices (GMP) and good laboratory practices (GLP) under the Drugs & Cosmetics Act. These inspections, which are conducted by the state drug licensing authorities and DCGI, audit manufacturer's compliance on sanitation, hygiene, self-inspection, quality audits, prevention of cross-contamination and bacterial contamination during production, among other critical areas.

It was apparent that the DCGI office was planning to undertake massive risk-based inspections pan-India after the World Health Organization (WHO) held Indian pharma companies accountable for exporting contaminated medicines in the aftermath of deaths of several children in Gambia and Uzbekistan.

The state and central licensing authorities recently sounded Noida-based Marion Biotech and Haryana-based Maiden Pharma following reports from Uzbekistan and Gambia of children dying after using cough syrups manufactured by these companies. The Union Health Ministry has also warned the drug regulator authorities in States and Union Territories against the use of the excipient propylene glycol supplied by Delhi-based Maya Chemtech India, since it has been allegedly supplying product, whose quality does not confirm to claims as per IP 2018, addendum 2021 in respect to identification. Its samples contained ethylene glycol. Following the deaths in Gambia and Uzbekistan, and the WHO holding Indian pharmaceutical companies accountable for exporting contaminated medicines, the Union Health Ministry held a two-day brainstorming conclave in Hyderabad. They deliberated upon improving the quality of medicines, and aspects that needed to be streamlined to ensurethe quality of pharmaceutical products. The ministry warned of action against manufacturers of substvandard or spurious medicines.

They also discussed on going about makingthe drug regulatory system transparent and verifiable through principles of uniform standards, sturdy structures for compliance and enforcement and capacity enhancement.

They felt that technology could play the role of a facilitator and enabler for uniformity, transparency and accountability.The need for a uniform portal with a national database with integrated legacy systems was also discussed. Shifting from minimal to optimal standards with provision of periodic reviews, global benchmarking for not only drugs but also medical devices, were dwelt in detail.

Several participants underlined the importance of creating citizen facing measures to strengthen confidence on the quality of drugs along with portals for grievances and effective recall measures.

As was discussed in the conclave on "Drugs: Quality Regulations & Enforcement", it is of vital importance to ensure that medicines and medical products produced in India are of the highest quality for both domestic and export markets. Within the federal democratic structure of the country, both the Centre and States are required to work in harmony and synergy to ensure that the country establishes robust regulatory systems.

All said and done, the latest effort by the drug regulators is too late and the regulator needs to be more transparent to reveal the actual inspection reports and names of the errant companies. Even though the media published them widely, a confirmation is yet to come from the DCGI office. In such a backdrop, the action cannot be seen as a serious effort since structural reforms are needed and not just action against individual companies. It can be termed just a cosmetic or half-hearted measure. The name of the companies which lost their license is not being revealed. Same is the case about the drugs they have manufactured. What is apparent is that the writing is on the wall for Indian pharmaceutical companies into manufacture of substandard medicines.