Poor Quality 'Oflovis' Drug Supplied By Himachal Based Pharma Firm: Chennai Court Imposes ₹1.2L Fine On Partners

A Chennai Court has found the partners of Himachal based Quixotic Health Care guilty of supplying poor quality variants of the drug 'Oflovis', thereby contravening Sections 18(a) and 18(B) of Drugs and Cosmetics Act, 1940.

Before the XV Metropolitan Magistrate, Georgetown, three of the pharmaceutical firm's partners had pleaded guilty and filed guilty memo. It is pertinent to note that the similar case against A1 -M/s.Quixotic Health Care and A2-Mr.Sathish Singal who was the other partner representing the firm was split from the original case involving all the partners. The case that was split came to be disposed of in December 2021 after A2 pleaded guilty.

In September 2012, the samples were tested in Central Drugs Laboratory, Kolkata and found to be of substandard quality. Noting the allegations made by the Drug Inspector (complainant) who drew the sample from a medical store in 2012, the Magistrate observed that:

"...On chemical analysis, the sample was found to be not of standard quality. In the Analysis Report 21.09.2012, the Government Analyst, found that the sample does not conform to claim with respect to the content of Ofloxacin. In the Analysis Report, it is stated that the said batch of drug contained 68.77% of the Ofloxacin, instead of allowed limit of 90% to 110%".

In the current case, the three partners were found guilty of offences u/s 18(a)(1) R/w 27(d) and 18B R/w 28A of Drugs and Cosmetics Act 1940. 

Section 18(a)(1) prohibits manufacture/ sale/ distribution etc. of any drug which is not of standard quality or is misbranded, adulterated or spurious. Similarly, Section 18B stipulates that any person who holds the license for manufacture/ sale/ distribution etc. of drugs must maintain prescribed records, registers and other documents and furnish them to any officer/ authority discharging functions under the Act.  Section 27(d) and Section 28A lists the punishment for both of the offences.

A show-cause memo was sent to the pharmaceutical firm in 2013 along with a copy of the analysis report and one of the samples. Afterwards, an investigation was conducted on its premises which revealed that the firm has not adhered to the manufacturing practice as per Schedule M of Drugs and Cosmetics Act. The show-cause memo also received no response from the accused even after 30 days and the Drugs Inspector obtained sanction from the Drugs Controller General of India to prosecute the accused. Accordingly, a private complaint under Section 200 CrPC was filed by the complainant Inspector for contravention of the Drugs and Cosmetics Act.

The court noted that Section 27(d) is a residuary provision that talks about punishment for offences that do not come under the categories specified in sections 27(a) to 27(c) of the Act pertaining to manufacture/ sale/ distribution of certain substandard drugs. Section 27(d) is usually invoked to punish the offenders for serious offences like selling expired drugs as well as for lesser offences like minor violations of license conditions.

"...In this case, the accused have license to manufacture the drugs. One batch of drugs manufactured by the 1st accused failed to satisfy the required quality. It is not the case of the prosecution that there is any injury or harm caused to any public. Further, it is not the case of prosecution that the accused had previously indulged any violations. The accused assured that this type of lapses will not occur in future. Therefore, the accused deserves lenient consideration by this court", the court clarified.

Therefore, the court deemed it fit to utilise its discretion to impose a lesser punishment under Section 27(d) which usually mandates minimum imprisonment for a period of one year. 

While holding that all the accused must be kept in custody till the court raises on the day judgment was pronounced, the Metropolitan Magistrate A.Muralikrishna Anandan also imposed Rs 20,000/- as fine on each partner for contravening Section 18(a) (1). Additionally, each partner was directed to pay another Rs 20,000/- as compensation for violation of Section 18B, bringing the total amount of fine imposed on the three partners to Rs. 1, 20,000.

"The accused have supplied 'Oflovis (Ofloxacin Oral Suspension)' to various sellers and distributors. The said drug has been widely used by the public. Since the 1st accused is the manufacturer of the drugs and it is supposed to maintain the required quality all the time. However, the accused 3 to 5 are not managing partners. Considering the same, the minimum fine of Rs.20,000/- can be imposed", the court concluded.

In the related case that was split from the current one, the Georgetown Court had imposed Rs 30,000/-  each as fine on the Managing Partner and the firm in December 2021.

R.Chander, Additional Central Government Standing Counsel appeared for the complainant and Advocate Davidson Ambrose represented the accused.

Case Title: Union of India represented by Its Drug Inspector, Mr.V.S.Prabhakar v. Sanjeev Singal & Ors.

Case No: CC.No. 2791 of 2014

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