In August 2013, government analysts working at the Drug Testing Laboratory in Chennai under the Tamil Nadu Drug Control Administration received as a matter of routine, drug samples from the Drug Inspectors in Gudiyattam, Vellore. The samples in question were supposedly of Glipizide, a drug used to treat Type 2 diabetes.
Drug inspectors routinely purchase such samples and send them to government laboratories for testing as prescribed in the Drugs and Cosmetics Act 1940. These particular tablets were allegedly manufactured by the Tamil Nadu-based Alfred Berg & Co Pvt Ltd and had been purchased in bulk by the Tamil Nadu Medical Services Corporation, a government company responsible for purchasing and distributing drugs to government-run hospitals across the state of Tamil Nadu.
The most usual adverse outcome during the testing process by government analysts is for the drug to be declared as “Not of Standard Quality” (NSQ) because of its failure to comply with the standards laid down in the Indian Pharmacopoeia. Except in this case, the government analysts made the shocking allegation that the tablets in question contained not Glipizide as mentioned on the labelling of the samples sent to them but instead another drug called Glibenclamide!
While Glibenclamide is also used to treat Type 2 diabetes, it should not be used as a substitute for Glipizide without the advice of a doctor. It takes the human body three to four times longer to metabolise Glibenclamide when compared to Glipizide, thereby increasing the possibility of hypoglycaemia in patients who unwittingly take one drug instead of the other.
The allegations in question were so scandalous that the drug inspectors from the Tamil Nadu Drug Control Administration, instead of merely summoning manufacturing records as is the usual practice during such investigations in India, visited the manufacturing premises of Alfred Berg & Co to inspect the manufacturing facility for regulatory compliance. The inspection allegedly revealed shocking lapses at the facility.
Not only did the drug inspectors accuse the facility of lacking a “separate quality assurance department” as mandated by the GMP code laid down in Schedule M to the Drugs and Cosmetics Rules 1945, but also alleged that the staff were unable to produce quality control records that they were mandated to retain under the law. The staff had apparently claimed to the drug inspectors that they had sent their quality control records to their headquarters and did not maintain records at the manufacturing facility.
Similarly, when the raw materials register and packing material register were sought by the inspectors, the director of the company produced a compact disk that was supposed to contain these records but which allegedly did not open on the computer. In other words, the most critical records documenting the manufacturing process were not accessible to the drug inspectors and in the records that were accessible, the inspectors alleged several discrepancies.
Subsequently, a criminal complaint filed before the Judicial Magistrate at Gudiyattam on December 8 2014 by the Drug Inspector Mrs SL Dheivanar alleged that Alfred Berg & Co’s manufacturing facility did not adhere to the GMP code; that the premises were congested with raw material that was not properly labelled and that required records were not being maintained by the company. The complaint filed in court also “observed” that Alfred Berg & Co was “simply manufacturing the drugs first and then creating records thereafter” and that the investigating team was of the opinion that “the manufacturer did not produce the proper and genuine records” in order to cover their mistakes.
The drug inspector also accused Alfred Berg & Co of substituting Glipizide with Glibenclamide for purely profit motives; the cost of Glipizide was Rs 9,000 per kg, while the cost of Glibenclamide was only Rs1,900 per kg. If these allegations against the company were in fact true, Alfred Berg & Co. presumably profited enormously from this substitution (regardless of whether it was a mistake) because as per the complaint filed in court, it had sold a whopping total of 5,67,000 Glipizide tablets to the Tamil Nadu Medical Services Corporation!
Given the seriousness of the allegations, it was no surprise that the drug inspectors sought to prosecute Alfred Berg & Co under a provision of the Drugs and Cosmetics Act 1940 that carries a maximum punishment of life in prison and a fine that could go up to three times the value of the consignment seized. In an ideal world, this was exactly the kind of case that should have been swiftly prosecuted.
The Indian legal system, however, has its own logic. As we discovered to our utter astonishment, this case which was filed in December 2014, had not proceeded to trial as of March 2022! According to the e-courts record for this case, the court was unable to serve summons on the company despite the fact that Alfred Berg & Co is headquartered in Chennai, merely 167 kilometres away from Gudiyattam. At some point in 2016, the Judicial Magistrate finally issued non-bailable warrants against the company, thereby clearing the path for the police to arrest the accused management personnel in charge of the company.
Yet as of 2022, according to the e-courts record, these warrants had not been executed. In order to double check the accuracy of the e-courts records, we filed an application under the RTI Act 2005 with the Drug Inspector, Vellore, who confirmed that the case continues to be pending before the court. During this very time period, we discovered that Alfred Berg & Co has been actively litigating before the Madras High Court in three different criminal cases filed against it by the Tamil Nadu Drug Control Administration over quality issues.
In a fourth case, we discovered that four representatives of the management of Alfred Berg & Co appeared before the Metropolitan Magistrate at Sadiapet, Chennai, in May 2016, to plead guilty in a prosecution filed by the Tamil Nadu Drug Control Administration under the Drugs and Cosmetics Act 1940. It is thus a mystery to us as to why the state has not been able to secure the presence of the management of Alfred Berg & Co in the prosecution before the court at Gudiyattam.
Excerpted with permission from The Truth Pill: The Myth of Drug Regulation in India, Dinesh S Thakur and Prashant Reddy T, Simon & Schuster India.
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