In the last two posts, I explained how investigations are conducted in Andhra Pradesh and Maharashtra. In this post, I will discuss two investigations in Vellore district of Tamil Nadu. Unlike other states, both the investigations in Vellore are thorough and comprehensive. As usual, the court documents are acessible by clicking on the headings below.

(A) The Drugs Inspector, State of Tamil Nadu Alfred Berg & Co. Pvt. Ltd. and Ors. before the Honourable Court of Judicial Magistrate Gudiyattam: In this case, the drug inspector drew samples of Glipizide tablets manufactured by Alfred Berg & Co from the premises of the Government Hospital, Gudiyattam, Vellore and sent it for lab analysis on August 22, 2013. The lab report which was returned on December 10, 2013 reported that the sample didn’t conform to the IP specification for Glipizide and that the sample in question was actually Glibenclamide. The drug was therefore declared to be ‘Not of Standard Quality’ and ‘Spurious’. Both Glipizide and Glibenclamide are anti-diabetic drugs from a class of medication known as ‘sulfonylureas’. While the latter was discovered around 1966, the former has been on the market since 1984. There can be serious medical complications for elderly diabetic patients who have consume Glibenclamide instead of Glipizide. In fact, a WHO report comparing the two drugs says “The data unequivocally recommends against the use of glibenclamide in elderly patients.”

Upon receiving the govt. analyst’s report, the drug inspector inspected the stocks of the Government Hospital on December 18, 2013 and discovered that there was nothing left of the stock. A notice was served on the chief pharmacist of the government hospital to disclose the details of the person from whom the drugs were procured. The chief pharmacist responded on the same day disclosing that the drugs had been procured from the Tamil Nadu Medical Services Corporation Ltd. (TNMSC) – the company responsible for all drug procurement on behalf of the Government of Tamil Nadu. The TNMSC warehouse confirmed that the drugs in question had in fact been acquired from Alfred Berg & Co.

Once the drug inspector established that Alfred Berg & Co was in fact the manufacturer, the inspector from Gudiyattam teamed up with the Drug Inspector of the district where the Alfred Berg & Co factory was located and together conducted a joint inspection of the company’s manufacturing plant. A showcause notice was served on the company along with a request to submit particulars like batch manufacturing records, analytical report of raw materials, purchase details, analytical reports of the finished product, raw material register, packing material register, purchase details of raw materials etc.

The joint-inspection was carried out on January 8, 2014. During the investigation, the drug inspectors discovered shocking lapses in following good manufacturing practices, especially in maintaining proper records of manufacturing and quality control process. The Batch Manufacturing Records showed that there was a long gap of around 12 days between granulation and compression and surmised that the long gap possibly led to the mix up in labelling the drugs. The inspectors also noted that the records did not contain in-process details such as hardness test, thickness test, friability test and disintegration test. Similarly, the inspectors noted that the company had analysed only the finished tablet and not the final product (i.e. after the tablet has been packaged). With respect to the GMPs, the drug inspectors noted that the “whole premises is congested with ready for compression granules, compressed tablets, packing materials and raw material without any proper labelling and strips of final packing of Glibenclamide four batches were kept together without any demarcation.” It was also discovered that the company did no stability testing on this product.

As far as the company’s record keeping is concerned, the drug inspectors noted that the company did not maintain required records and registers as per Schedule U of the Drugs & Cosmetics Act and that it appeared that the company was simply manufacturing the drug first and was creating records thereafter. In particular, it was noted that the “Records of Raw Materials” were not maintained properly. The inspectors also opined that “the manufacturer did not produce the proper and genuine records to investigate and inspection to cover their mistakes”.

The complaint then makes an explosive allegation that the mislabelling of Glibenclamide for Glipizide was done intentionally for profit since the former was priced at Rs. 1900 per kg while the latter was priced much higher Rs. 9000 per kg. This allegation is supported by the fact that the company did not maintain proper Records of Raw Materials; a document which would have helped the inspectors conclusively determine whether the mixup was deliberate or a genuine error. When bank and purchase details for raw materials were requested for by the drug inspector, the company claimed that it didn’t maintain such records at its manufacturing site; and that such records were maintained at its head office and requested more time. A subsequent response from the company noted that the company did not maintain a stock register or packing material register for the year 2012-13.

In order to estimate the scale of profits made by the company, it may help to assess the number of tablets sold by the company: Alfred Berg & Co reportedly manufactured 5,75,400 tablets and released 5,67,000 tablets for sale. Of these 1,57,000 tablets were sold to the TNMSC warehouse in Vellore, while 2,60,000 + 1,50,000 tablets were sold to the TNMSC warehouse in Kanchipuram. As you can see, in addition to the risk to patients who consumed this drug, the public exchequer has been defrauded by such sales.

Ultimately, the drug inspectors decided to charge Alfred Berg & Co. along with its directors and quality control staff with the following offences:

(i) Section 18(a)(i) read with Section 17B(d) of the said Act for having manufactured for sale and sold a “spurious drug”;

(ii) Section 18(c) read with Rule 74(c) for failing to completely test the finished product of the said batch of subject drug which is punishable under Section 27(d) of the said Act;

(iii) Section 18(c) read with Rule 74(d) for having failed to maintain the required records and registers as per Schedule of the Drugs and Cosmetics act, 1940 which is punishable under Section 27(d) of the said Act.

This case is one of the rare prosecutions that we could obtain which specifically charges the accused with failing to maintain records as required by the GMPs outlined in Schedule M & Schedule U of the Drugs & Cosmetics Act. Most importantly, the TNMSC blacklisted Alfred Berg & Co for all tenders till March, 2019. It is very unlikely that the blacklist was applied toward the purchase of this drug; Alfred Berg & Co figures on earlier blacklists by the TNMSC; and yet it managed to sell this drug to the state.

We do not have details on the current status of this case.

(b) Drug Inspector, State of TN v. Res Sancta & Othrs. before the Judicial Magistrate Court, Tiruvannamalai-I: This case was relatively simple compared to the one above. The Drug Inspector had drawn a sample of Dolocold Suspension 60 ml from a pharmacy in Vellore district and sent the sample for testing on August 16, 2013 to the Drugs Testing Laboratory, Tamil Nadu. The test report from the government lab was returned on March 20, 2014 – a full 7 months later – declaring the sample to be NSQ because the content of Phenylephrine Hydrochloride in the sample was only 27.82% of what was declared on the label. Dolocold suspension is reportedly a Fixed-Dose-Combination of Paracetamol (125 mg), Phenylephrine (2.5 mg) and Chlorpheniramine Maleate (1 mg). The list of indications for this FDC include everything from allergies, cold, ear pain, fever, flu, hay fever, headache, joint-pain, nasal decongestant, toothache, runny nose.

Although, the brand name appears to be owned by Micro Labs Ltd., the manufacturer of the drug in this case was Res Sancta, a partnership firm based in Solan – Himachal Pradesh. The Drug Inspector was able to establish the supply chain from the pharmacy to the manufacturer without much difficulty.

Subsequent investigation in this case wasn’t as detailed as the previous case; perhaps because the manufacturer was more co-operative. In its defence, the manufacturer tried arguing that the control sample it retained was tested again and found to comply with standards but the complaint noted that no documentary evidence was submitted in support. Other defences proffered up by the manufacturer were similarly dismissed by the drug inspector. Ultimately a prosecution was launched against the manufacturer and all the partners were charged under Section 18(a)(i) and Section 27(d) of the said Act.

(C) Other investigations: In addition to the above prosecutions, there are several other cases (available here: 1, 2, 3, 4 & 5) where investigations into NSQ drugs haven’t always resulted in prosecution of the manufacturer because most drug controllers follow a set of Guidelines laid down by the DCC which recommends prosecutions only in the most serious cases. Even when the drug inspector establishes cuplability with the help of the government laboratory, no prosecution is initiated. In such cases, the drug inspectors in Tamil Nadu recommend that they be referred to either to the state where the manufacturer is located or alternatively suspend the licence for a brief period of time.

Among the states who responded to our RTI inquiries, Tamil Nadu seems to be the best in conducting investigation into the prevalence of NSQ drugs. The Alfred Berg & Co case is demonstrative of the depth of the problem with sub-standard drugs in India. Although the complaint isn’t conclusive on whether the mislabelling of Glibenclamide for Glipizide was done with criminal intent, the medical fact remains that patients who have consumed the drug in question may have experienced serious adverse events. For elderly citizens, such misbranding may have resulted in potentially deadly consequences. We cannot conclusively prove that such mislabelling causes deaths or even that it seriously affected diabetic patients because pharmacovigilance systems are practically non-existent in India.

This case also demonstrates the difficulties I faced while trying to advocate the dangers of sub-standard drugs; although the facts of the case point to the medically supported conclusion of possible dangerous outcome, I don’t have evidence readily available to substantiate it. Without such proof, it is difficult to convince a non-specialist audience that sub-standard drugs are a serious hazard to public health in India; especially when the specialists chose to look the other way. It appears that public discourse in India requires actual body-bags and visible injuries to accept that there is a problem. In the case of sub-standard drugs, it will most likely take a tragedy of epic proportions to force both the government and the Supreme Court to intervene into the governing issue of drug regulation.

Sadly, the Supreme Court of India thinks this is an academic exercise and refused us an opportunity to make our case.