In my last post, we looked at the investigation process followed by drug inspectors of the Andhra Pradesh Drug Control Administration in three different cases. In this post, lets look at the investigation process followed by the drug inspectors of the Maharashtra Food & Drug Administration in two different zones – Nagpur & Jalna. Our efforts to procure criminal complaints from the Aurangabad zone and Greater Bombay zone have been stalled because of reluctant Public Information Officers.

We learnt of these complaints from the Prosecution registers that we procured from the headquarters of the Maharashtra FDA through the RTI Act. The Maharashtra FDA is one of the better organised, although not as competent as the state authority in Tamil Nadu. The RTI responses are linked to the respective case headings below.

(i) Drug Inspector, State of Maharashtra v. Medisys Biotech Private Limited & Its Directors before the Court of Chief Judicial Magistrate, Nagpur: This was a relatively simple case, which was investigated and prosecuted within a short period of time. The starting point for this case was when the Drug Inspector of the Nagpur Zone, drew samples of ‘Neuropat-NV’ tablets (Vitamin B1) from a pharmacy in Nagpur. The drug in question was manufactured by Medisys Biotech Pvt. Ltd. which is a pharmaceutical company based out of Himachal Pradesh (HP) – a state which is the fountainhead of Not of Standard Quality (NSQ) drugs in India.

The sample was drawn on February 3, 2012 and sent shortly thereafter to the Drug Control Laboratory in Mumbai for testing. The lab sent back the test report declaring the drug NSQ on April 20, 2012. The report explained that the drug was NSQ because “Content of Vitamin B1 in the sample is less than the permissible limit (i.e. 18%) of the labelled amount.” Thereafter, the drug inspectors traced the supply chain by serving notices on the pharmacy from where the drug was sampled. The pharmacy revealed the name of the trader who had sold the drug – this trader in turn named another trader, who in turn revealed that it had procured 20,000 tablets from the manufacturer – Medisys Biotech.

The drug inspector thereafter travelled to HP on May 19, 2012 and personally served on Medisys Biotech, a copy of the analyst’s report and sealed portions of the samples drawn from the pharmacist in Nagpur. The company was also required to furnish details on its drug licence, its manufacturing record, testing record, analytical record, purchase detail of raw material, sale details of the drug in question. The company was informed that they had a right to appeal the findings in lab report by having a portion sent to the Central Drug Laboratory in Kolkata for confirmation. The company however declined to exercise the option and co-operated with the drug inspector by furnishing some of the required details. The investigation revealed that the batch strength was a total of 100,000 tablets. On receiving permission from the Joint Commissioner, the Drug Inspector initiated prosecution by filing a criminal complaint before the Court of the Chief Judicial Magistrate on August 24, 2012

The investigation was wrapped up in a record time of less than 7 months and the criminal complaint is adequate to ensure a successful prosecution especially since the manufacturer declined to challenge the test report. The complaint could however include more details on why the drugs had such low quantities of the API. In specific, to ensure a water-tight complaint, the drug inspector should test even the reference samples which are required to be stored by the manufacturer as a part of the GMP requirements under Schedule M of the Drugs & Cosmetics Act, 1940. Testing these samples will eliminate any claims by the manufacturer against the storage conditions at the pharmacist. In addition, the Drug Inspector should have mentioned whether the manufacturer had any previous run-ins with the law.

The current status of the case is not known.

(ii) Drug Inspector, State of Maharashtra v. Perennial Medicare & Ors. before the Court of Chief Judicial Magistrate, Nagpur: The starting point in this case was the drawing of samples on February 29, 2012 by a Drug Inspector from a pharmacy in Nagpur. The samples in question were OPTIMOX-CV powder for oral suspension – the Optimox brand belongs to Troikaa Pharmaceutical Ltd. Although the supply chain led the drug inspector to Troikaa in this case, the company quickly proved that it wasn’t the manufacturer and that it had procured the drug from Perennial Medicare, a partnership firm based in the state of Himachal Pradesh (HP), which accepted that the drug in question was its product.

The investigation had been triggered by the fact that the sample was found to be NSQ in a test report of the Drugs Control Laboratory, Mumbai on May 2, 2012. The government analyst had declared the sample NSQ because “Content of Calvulanic Acid in the sample (when freshly prepared) is less {1.77% of the labelled amount} than IP 2010 limit as given in the protocol and the content of Clavulanic Acid in the sample (when stored) is less {0% of the label amount} than IP 2010 limit as given in the protocol”. Our research on the internet tells us that Optimox is a FDC consisting of Amoxicillin and Clavulanic Acid – both are antibiotics. If the Clavulanic Acid content is close to zero, as is the case in the situation, it will result in the antibiotic combination not working as expected. Since such antibiotics are most commonly used to combat infections, the failure of the drug to work can lead to deadly consequences in a patient. In this case, the batch in question had a total of 8984 bottles of this drug, all of which were sold to Troikkaa Pharmaceuticals, of which a total 2,548 bottles were supplied to Troikaa Pharmaceutical branch in Nagpur which then sold 350 bottles to the pharmacy from where the Drug Inspector had drawn the samples.

Upon receiving the NSQ report, the Drug Inspector dispatched a copy of the test report along with the sample to Perennial Medicare on May 11, 2012. The complaint then records how the accused company replied on June 13, 2012 claiming non-receipt of the test report, to delay the investigation. According to the drug inspector, these tactics were deliberately used because the drug in question was reaching its expiry date. Although the complaint does not clearly outline the consequences of the batch reaching its expiry date, we can presume that the prosecution would be jeopardised because the accused would not be able to exercise his right to appeal against the test report to the Central Drug Laboratory (CDL). In any case, it appears that on receiving confirmation from Troika in July, 2012 that Perennial Medicare was indeed the source of the NSQ drugs, the Drug Inspector responded by seizing the stock from the pharmacy in Nagpur, almost 2 months after the test report had already declared the sample NSQ.

Although the prosecution in this case was initiated quite quickly, the fact remains that this complaint is weak on two counts. Not only did the Drug Inspector fail to record the response of Perennial Medicare; there has been no attempt to procure the batch manufacturing records and other details. If the manufacturer was refusing to volunteer this information the Drug Inspector should have teamed up with his counterparts in either HP or at the CDSCO north zone to conduct a surprise raid to seize all the documents in question. Instead the Drug Inspector has filed a weak criminal complaint.

We are unaware about the current status of this prosecution.

(iii) Drug Inspector, State of Maharashtra v. Colinz Laboratories Ltd., Shefa Healthcare Pvt. Ltd. & Ors. before the Court of Chief Judicial Magistrate, Jalna: This complaint was perhaps one of the shortest complaints that we have seen. Basically, the Drug Inspector, drew a sample of the drug, named ‘Pasam’ on February 29, 2012 and dispatched it to the government lab for testing on March 1, 2012.

The lab replied with the test report on October 8, 2012 (7 months after receiving the sample) declaring the drug to be NSQ. The drug in question, ‘Pasam’ is a combination of Simethicone (an anti-foaming agent which is used in treating bloating or discomfort caused due to excessive gas) and Dicycloverine (an anticholinergic which is used to treat muscle spasms and cramping in the gastrointestinal tract – basically a muscle relaxant). The sample was declared NSQ with the remark that “The content of the dicyclomine hydrochloride in the sample is less (23.30% of the said amount) than the permissible limit. (Permissible limit:- Not less than 90% of the said Amount)”.

On receiving the report, the drug inspector served notice on the pharmacist who reported that the drug was purchased from Colinz Laboratories – the company which is located in Mumbai, also appears to own the ‘Pasam’ brand. When notice was served on Colinz, it responded to the drug inspector that the drug was actually manufactured under a loan licence by Shefa Healthcare Pvt. Ltd. and provided the details to that effect. The company also asked Shefa Healthcare to provide with the Drug Inspector the necessary documents regarding the manufacture of this product. The complaint does not state which documents which were requested and whether Shefa Helathcare actually provided any of these documents. Instead the complaint directly skips to the fact that the HQ granted sanction to prosecute on October 20, 2012. It then took the Drug Inspector, another 5 months to actually file the complaint on March 21, 2013. Thus, the complaint was filed more than year after the sample was drawn.

Unlike other drug inspectors, this particular inspector charged the pharmacist as well from whom the drugs were sampled.

Of all the complaints that we studied for this piece, this is one of the more poorly drafted. Unlike other cases where the manufacturer was located in an entirely different state, the manufacturer in this case was located in the same state. Although the Drug Inspector for Jalna District would not likely have jurisdiction over a manufacturer located in Mumbai, it would have been considerably easy to co-ordinate with the drug inspector in that zone since both of them belong to the same agency. However this was not done.

We do not have further information on the current status of this prosecution.

(iv) Drug Inspector, State of Maharashtra v. Akums Drugs & Pharmaceuticals Ltd.& Ors. before the Court of Chief Judicial Magistrate, Jalna: The drug sample in this case was drawn on July 17, 2012 by the Drug Inspector from a company with a licence for wholesale. The drug drawn from the market was “Acemiz-S”, which is a FDC of Paracetamol, Serratiopeptidase & Aceclofenac Tablets. While paracetamol is used to treat fever, Aceclofenac is a non-steroidal anti-inflammatory drug which is used to provide relief from pain and inflammation of the joints. Serratiopeptidase is supposed to have anti-inflammatory properties, although this remains controversial. This FDC is indicated for pain relief and swelling of joints. Although many websites indicate Lupin as the manufacturer of the brand, it appears that Lupin is only the owner of the brand because in this case Lupin indicated to the drug inspector that although it marketed the drug, the manufacturer was Akums Drugs & Pharmaceutical Ltd. whose plant is located in Uttarakhand.

The Drugs Control Laboratory, Aurangabad declared the sample to be NSQ with the comment that “The Content of the Serratiopeptidase in the sample is less (24.93% of the said amount) than the permissible limit:- Not less than 90% of the said Amount.)”.

Once the supply chain to Akums was established, the Drug Inspector served a copy of the test report and sample on the company and asked them to furnish the “documents”. The complaint doesn’t mention which documents were requested. The complaint then notes that Akums did provide some documents but neither mentions nor discusses the content of those documents. The company refused to confirm whether the sample belonged to it because the drug inspector had supposedly not established the supply chain to the company. After receiving permission from HQ a prosecution was lauched on March 19, 2013.

Once again this complaint is short on details with no mention of the details contained in the batch records or even whether the inspector has studied the batch records to establish compliance with manufacturing standards.

It is interesting to note the following remarks of the Bombay High Court, about the drug inspectors in the state: In the case of Shivkumarv. Food & Drugs Administration, State Of Maharashtra MANU/MH/0588/2010, the High Court made the following scathing observations against the Maharashtra Food & Drug Administration after scrutinising an investigation it conducted:

I conclude that the Food and Drugs Department and its officers right from the cadre of Food Inspectors to Joint Commissioner do not have any legal knowledge, legal skill and seriousness with which the provisions of these Acts concerning human health is required. They are casual, callous and hardly concerned. Relevant and concerned provisions/amended provisions of Code of Criminal Procedure are not even known to them to make use thereof. They are making cases only to show that cases are being prepared and instituted in courts and finally tell the people that courts have discharged or acquitted the accused persons and thus save their skin. In my opinion, Government is simply wasting money on Food and Drugs Department and serious view for revamping this department will have to be taken by the Government with strict `accountability’ to be fixed for each and every officer.

These four cases highlight the following: First, the content of the active ingredient as established by the government laboratories is woefully short of what is on the label. In all the cases that we reviewed, there is very little information about whether the government laboratories established an impurity profile for the samples they tested. We do not know what kind of potential adverse events would result from the consumption of these substandard drugs; all we could document was lack of effect. Second, the inspectors clearly do not seem knowledgable about the process for investigation or the science behind manufacture of drugs. It appears that they have no formal training in how to conduct scientific investigations and prepare water-tight prosecutable cases. Third, the comment of the court speaks for itself.

We rely on the competence of the drug inspectors, the regulatory framework and the criminal justice system in the country to keep the drug supply safe in the country. As one can see from these cases, there are gaping holes at each step. And the industry is only too happy to exploit these gaps. Sadly, the highest court in the land thinks this is an academic exercise. Unfortunately, this level of dysfunction and incompetence affects the health of over a billion people who live in India.