The US Centre for Disease Control and Prevention (CDC) recently raised the alarm when eye drops made by Global Pharma Healthcare in Chennai resulted in eight cases of blindness in the US. The CDC also alleged that the eye drops contained Pseudomonas, a drug-resistant bacteria, which have further resulted in infections and deaths. Global Pharma recalled the questionable eye drops from the US market. However, Tamil Nadu’s FDA defended the manufacturer. Global Pharma has a portfolio of over a dozen eye care drugs listed on their website which are probably available and are being used by Indian patients as well. The same company also makes cardiovascular and antibiotic drugs among many other critical healthcare products. Should we rubbish the findings of the CDC because the Tamil Nādu FDA says there is nothing wrong?
According to media reports this week, Pfizer has suspended the sale of Magnex, Magnex Forte and Zosyn – drugs used to treat infections in patients in intensive care units. The contract manufacturer has reported deviations in manufacturing. Pfizer seems to have shifted onus to their contract manufacturer, Astral Steritech, while taking the high moral ground for themselves. The marketeer and manufacturer share the responsibility for the quality of the drug reaching the consumer. Children losing the lives in Gambia and Uzbekistan using the cough syrups made in India is still fresh in our minds.
Apparently, the PMO is concerned about the bad image being created by some of Indian pharma manufacturers. Hence, health minister, Mansukh Mandaviya called a meeting with the promoters and CEOs of a few big Indian pharma companies. Mandaviya’s message was that these companies should tighten the quality check within their supply chain network including their vendors. The new Drug Controller General of India, Raghuvanshi has been actively auditing the manufacturers and some companies had their manufacturing licenses cancelled or suspended.
Are these knee jerk reactions or search for sustainable solutions?
While our reputation of being global pharmacy is important, the bigger cause of concern is the domestic consumer who buy life saving drugs from some of these manufacturers whose quality has been flagged by few importing countries. Finding a solution by seeking India’s flagship companies like Glenmark, Sun, Cipla or Lupin to tighten the quality of the products being manufactured by them will not resolve the ongoing issue. These companies have skin in the game and will not play with their and country’s reputation by compromising on drug quality or good manufacturing practices at their sites. They have strong internal controls and are regularly supervised by the regulators of the importing countries. I will trust paracetamol made by Cipla as much as one made at GSK plant. These companies constitute over 80-90% of India’s pharma manufacturing for domestic and global markets and do not need close regulatory supervision.
We are talking about 10-20% of the manufacturers who operate under the radar. Small minority in this category is driven more by profit motives instead of a value for human lives. They “manage” to get the manufacturing licenses from state or central drug regulators and possibly have inadequate quality checks both for incoming raw material and outgoing final product. They also find ways to export some of their consignments which result in variable patient outcomes.
Some of these manufacturers reduce the prices of their products and get the upper hand in India’s L1 system (lowest price bidder) in government purchases. Their products may find way to government hospitals, Jan Aushadhi stores and mohalla clinics. Looking at recent March alert of NSQ drugs (Not of Standard Quality) on CDSCO website released on April 24, none of the major pharma companies were flagged. Majority of the defaulters of 48 total products are from Himachal Pradesh. Most of them have been found failing on assay and dissolution parameters. The NSQ drugs include ciprofloxin, amoxicillin, albendazole and even toothpaste (high bacterial content). Worrying, isn’t it?
Such manufacturers, though small in number, pose a real and substantial healthcare threat to Indian consumers first. Imagine the plight of Indian patients who use their products either due to cost consideration or through government institutions that may have bought them under L1 criteria? The state cannot be chasing quality just for export shipments while ignoring the domestic market. If we can fix the quality issue for the domestic consumers, global market issues will get resolved.
Who is responsible for the product quality and has skin in the game?
It is both manufacturers and the regulator!
The responsibility of the quality control must become the accountability of the business unit head who is the face for the consumer, retailer and the regulator.
Our regulators, responsible for licencing and supervision, need to ensure that the potentially unscrupulous elements in these 10-20% of the pharma players are supervised closely. Close attention must be paid to their manufacturing infrastructure, quality control mechanisms, if their chemists are qualified or do they have chemists at all, raw material handling and quality, matching their input and output and so on.
Another question is the quality of API’s and KSA (Key Starting Material). There is inadequate regulatory oversight on the raw material which becomes the part of final drug. Since Himachal Pradesh continues to occupy major space in NSQ list, why should the state drug controller not be held accountable for unending lapses in his jurisdiction and be replaced with a more competent official?
The CDSCO itself has witnessed its key officials coming under CBI scanner for corruption. The deputy drug controller general was arrested for accepting the bribes and served a jail term. We need to bring fixed tenures for state drug regulators and CDSCO officials.
The DCGI has traditionally been led by a technocrat who have not been successful administrators – we need to get an IAS or IPS to lead this organisation so that fear of the law could be enforced in the system.
Unless the regulator assumes responsibility for drug quality and manufacturers raise the bar on the accountability matrix, we will keep on facing product complaints and reputational challenges.
(Rakesh K. Chitkara is an expert on policy and regulations and has led public policy practice in Abbott Laboratories, General Electric, Dow Chemical, Rohm and Haas and Monsanto for over three decades).