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February 14, 2015

SHC tells officials to clarify registration status


February 14, 2015

The Sindh High Court on Friday directed the secretary and director general health to file comments on a petition challenging registration of a hepatitis vaccine.
Javed Iqbal Burki and others had submitted that a multinational company has unlawfully registered a drug used for treatment of hepatitis with the collusion of the Drug Regulatory Authority of Pakistan (DRAP).
They said that the respondent company did not observe legal formalities during the registration and got its priced fixed by the director biological of the DRAP bypassing the pricing committee, which was illegal.
It was submitted that the multinational company was selling the same drug with two separate brand names of the same generic salt and with different prices (A at Rs 13,000 and B at Rs 6,500) since March 2014, which is violation of the law.
Petitioner’s counsel Haider Imam Rizvi stated that the health department did not file comments despite the court notices while the Sindh Health Department has planned to buy the questionable medicine for Rs 130 million approximately.
He submitted that in terms of section 7 of the Drugs Act, 1976, it was only the registration board that can register the drugs and minutes of the registration board meeting with regard to ropegra also mentioned that evaluation report of the director biological drugs shall also be reviewed by the experts’ committee for biological drugs for further consideration of the registration board.
However, he submitted, that registration of drug has in fact purportedly effected by the director biological drugs through letter issued on September 19, 2013 as such facts were concealed by the director from other members of the board.
He said that the federal government was competent to fix the maximum price of the drug however, through the aforesaid letter, the director biological drugs has also prescribed the maximum price of the drug as Rs 6500 per vial, which was illegal as director biological drugs

had no authority to do so.
Respondent’s counsel Hyder Ali Khan said that all legal formalities were fulfilled during the registration process and the director biological drugs was empowered to register and fix price of the medicine.
He ruled out any connivance with board authorities for the registration of the drug and submitted that the proposed procurement was also challenged in civil matter and restraining order has been passed for procuring such drug.
The court directed the secretary health and director general health division Hyderabad to file their respective comments within a week where they shall deal the controversy specifically.
Adjourning the matter till February 25, the court directed that the interim stay order regarding the impugned notification shall continue till then.

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